Devices

Grafton DBM Matrix PLF

  • Model / Serial
    Multiple Lots - please see attachment
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally.
  • Product Description
    Grafton DBM Matrix PLF || Multiple Sizes || Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone.
  • Manufacturer
    Osteotech Inc
  • 1 Event

Manufacturer

Osteotech Inc
  • Manufacturer Address
    Osteotech Inc, 51 James Way, Eatontown NJ 07724-2272
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Grafton DBM Putty, Grafton DBM Gel, Grafton DBM Flex, Grafton DBM A-FlexTM, Grafton DBM Crunch, G...
  • Model / Serial
    see FSN | see FSN
  • Product Description
    Devitalized MD: Bone, graft, substitute
  • Manufacturer
    Medtronic Osteotech Inc.