FDA Adverse Event
Injury
Summary report: N
2520274-2013-01407
MDR report key: 3001353
·
Received March 13, 2013
Report
- Report Number
- 2520274-2013-01407
- Event Type
- Injury
- Date Received
- March 13, 2013
- Report Date
- February 15, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV
- Reporter Occupation
- NURSE
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 BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
PATIENT WAS IMPLANTED WITH DISTAL HUMERUS PLATES, ULNA PLATE, AND SCREWS ON AN UNKNOWN DATE. PATIENT CONSENTED FOR REMOVAL OF HARDWARE DUE TO HARDWARE PROMINENCE IN THE LEFT ELBOW. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013 AND THE HARDWARE WAS REMOVED WITHOUT COMPLICATIONS. THIS REPORT IS FOR AN UNKNOWN 3.5MM CORTEX SCREW. THIS IS 17 OF 27 REPORTS FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105074 | HWC | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |