FDA Adverse Event
Injury
Summary report: N
OASYS SCREW
MDR report key: 1859505
·
Received September 17, 2010
Report
- Report Number
- 9617544-2010-00373
- Event Type
- Injury
- Date Received
- September 17, 2010
- Date of Event
- August 31, 2010
- Report Date
- August 31, 2010
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- HWC
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE, WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.
Description of Event or Problem · 1
DURING THE SURGERY TO REMOVE THE OASYS IMPLANTS, THE SCREWHEAD WAS DISASSEMBLED RIGHT AFTER REMOVING THE ROD. THE SURGEON TRIED TO EXTRACT THE SCREW USING A DRIVER; HOWEVER, THE HEX PART RAN IDLE THUS THE SCREW COULD NOT BE EXTRACTED. AT LAST, THE SURGEON COULD EXTRACT THE SCREW USING PLIERS. THE SURGEON INQUIRED US IF THERE WAS A CASE IN THE PAST THAT THE SCREWHEAD WAS DISASSEMBLED IN THE PATIENT WHILE IMPLANTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OASYS SCREW | IMPLANT | HWC | STRYKER SPINE BORDEAUX | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |