FDA Adverse Event
Injury
Summary report: N
AUGMENT BONE GRAFT
MDR report key: 10131224
·
Received June 8, 2020
Report
- Report Number
- 3003897776-2020-00001
- Event Type
- Injury
- Date Received
- June 8, 2020
- Report Date
- May 29, 2020
- Manufacturer
- BIOMIMETIC THERAPEUTICS, LLC
- Product Code
- NOX
- PMA / PMN Number
- P100006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TIBIO-TALO-CALCANEAL FUSION WITH THE USE OF BONE GRAFT. ALLEGEDLY, THE PATIENT DID NOT FUSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 594225 | AUGMENT BONE GRAFT | FILLER, BONE VOID, SYNTHETIC PEPTIDE | NOX | BIOMIMETIC THERAPEUTICS, LLC | K20003010 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |