FDA Adverse Event
Injury
Summary report: N
SCREW, 2.0X16MM X-DRV LOCKING
MDR report key: 3111056
·
Received May 14, 2013
Report
- Report Number
- 0001032347-2013-00154
- Event Type
- Injury
- Date Received
- May 14, 2013
- Report Date
- May 13, 2013
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- JEY
- PMA / PMN Number
- PK081067
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT HISTORY OF THE IMPLANTED UNIT IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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
DISTRIBUTOR (B)(4) REPORTS A SCREW BREAKING DURING SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 213370 | SCREW, 2.0X16MM X-DRV LOCKING | BONE SCREW | JEY | BIOMET MICROFIXATION | N/A | 879220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |