FDA Adverse Event
Injury
Summary report: N
CORTEX SCREW
MDR report key: 2931164
·
Received January 28, 2013
Report
- Report Number
- 2520274-2013-00669
- Event Type
- Injury
- Date Received
- January 28, 2013
- Report Date
- January 9, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IMPLANT DATE REPORTED AS UNKNOWN DAY IN (B)(6) 2008.
Description of Event or Problem · 1
PATIENT SUFFERED FROM A MIDSHAFT HUMERAL FRACTURE AND WAS IMPLANTED WITH PLATE AND SCREW CONSTRUCT, AT A DIFFERENT FACILITY, ON AN UNKNOWN DAY IN (B)(6) 2008. ON AN UNKNOWN DATE, POST-OPERATIVE X-RAYS SHOWED A NON-UNION. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. PATIENT WAS REVISED WITH TWO PLATES, AUTOGENOUS ILIAC CREST BONE GRAFT, AND LAG SCREW COMPRESSION. THIS IS 7 OF 7 REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37589 | CORTEX SCREW | HWC | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Required Intervention |