FDA Adverse Event
Injury
Summary report: N
BIOMET MICROFIXATION MANDIBULAR FRACTURE/RECONSTRUCTION DEVICES AND PREBENT PLAT
MDR report key: 4231791
·
Received November 6, 2014
Report
- Report Number
- 0001032347-2014-00393
- Event Type
- Injury
- Date Received
- November 6, 2014
- Date of Event
- October 17, 2014
- Report Date
- October 14, 2014
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- HWC
- PMA / PMN Number
- PK113512
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON FOUND BROKEN TMS 2.4MM SCREWS. A REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2014. THE CUSTOMER FOLLOWED UP WITH THE SALES REP AND NO NEW INFORMATION HAS BEEN RECEIVED PER THE COMPLAINT FILE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 715213 | BIOMET MICROFIXATION MANDIBULAR FRACTURE/RECONSTRUCTION DEVICES AND PREBENT PLAT | TMS SCREW | HWC | BIOMET MICROFIXATION | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |