FDA Adverse Event
Injury
Summary report: N
CORTEX SCREW S.T. 4.5X40MM
MDR report key: 2151628
·
Received June 29, 2011
Report
- Report Number
- 8031020-2011-00148
- Event Type
- Injury
- Date Received
- June 29, 2011
- Date of Event
- May 28, 2011
- Report Date
- June 13, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- HRS
- PMA / PMN Number
- K972323
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT ON (B)(6) THE PATIENT UNDERWENT AN UNANTICIPATED REVISION SURGERY BECAUSE THE CORTEX SCREWS BROKE (THE FIRST SURGERY WAS ON (B)(6)). THE BREAKAGE OF THE SCREWS OCCURRED ON (B)(6) IN A NO-LOAD STATUS FOR THE PATIENT. THE SALES REP NOTICED THAT THE 6 SCREWS WERE BROKEN. THE SCREWS WERE USED WITH A NOT STRYKER TITANIUM NINE HOLES PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORTEX SCREW S.T. 4.5X40MM | IMPLANT | HRS | STRYKER OSTEOSYNTHESIS SELZACH | NA | U16780 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Required Intervention |