FDA Adverse Event
Injury
Summary report: N
2520274-2013-02869
MDR report key: 3132970
·
Received May 29, 2013
Report
- Report Number
- 2520274-2013-02869
- Event Type
- Injury
- Date Received
- May 29, 2013
- Report Date
- May 2, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- HSB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
ON AN UNKNOWN DATE, A PATIENT HAD REVISION SURGERY TO REMOVE AN UNKNOWN MATRIX RIB PLATE AND AN UNKNOWN QUANTITY OF LOCKING SCREWS. PATIENT WAS PREVIOUSLY IMPLANTED WITH MATRIX RIB PLATE AND LOCKING SCREWS ON AN UNKNOWN DATE. THE PATIENT WAS PULLING WEEDS WELL BEFORE HEALING TIME WAS COMPLETE, PULLED TOO HARD, AND CAUSED ONE SIDE OF THE PLATE TO COME LOOSE. NEEDED SURGERY TO REMOVE PLATE AND SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236801 | HSB | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |