FDA Adverse Event
Injury
Summary report: N
EXPERT END CAP SOLID EXTENS. 0 F/HN TAN
MDR report key: 3633504
·
Received February 19, 2014
Report
- Report Number
- 2520274-2014-00629
- Event Type
- Injury
- Date Received
- February 19, 2014
- Date of Event
- January 17, 2014
- Report Date
- January 21, 2014
- Manufacturer
- SYNTHES USA
- Product Code
- JDS
- PMA / PMN Number
- K033071
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.
Additional Manufacturer Narrative · 1
DEVICE USED FOR TREATMENT, NOT DIAGNOSIS.
Description of Event or Problem · 1
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2014, THE OPERATION OF PROXIMAL HUMERUS NAILING WAS PERFORMED. ABOUT ONE WEEK AFTER THE OPERATION, THE BACK OUT OF THE SPIRAL BLADE WAS OBSERVED. THE RE-OPERATION WAS DONE ON (B)(6) 2014. IN THE RE-OPERATION, THE END CAP WAS RE-TIGHTENED. THERE WAS A PROLONGATION OF SURGERY OF ABOUT 15 MINUTES. THIS COMPLAINT IS ON THE END CAP. THIS IS 1 OF 2 REPORTS FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106121 | EXPERT END CAP SOLID EXTENS. 0 F/HN TAN | JDS | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |