FDA Adverse Event
Injury
Summary report: N
3.5MM CORTEX SCREW SELF-TAPPING 22MM
MDR report key: 3173000
·
Received June 17, 2013
Report
- Report Number
- 2520274-2013-03436
- Event Type
- Injury
- Date Received
- June 17, 2013
- Report Date
- May 20, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- HWC
- PMA / PMN Number
- K112583
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, 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. : PLACEHOLDER.
Description of Event or Problem · 1
THE PATIENT WAS IMPLANTED WITH THE CLAVICLE PLATE ON (B)(6) 2013. ON AN UNKNOWN DATE, THE CLAVICLE PLATE IMPLANT BROKE IN HALF AND PATIENT PRESENTED WITH PAIN. A REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2013. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 5 OF 8 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273056 | 3.5MM CORTEX SCREW SELF-TAPPING 22MM | HWC | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |