FDA Adverse Event
Other
Summary report: N
STANDARD KOMPRESSOR SCREW 20 MM
MDR report key: 1981374
·
Received February 3, 2011
Report
- Report Number
- 3004608878-2011-00011
- Event Type
- Other
- Date Received
- February 3, 2011
- Date of Event
- December 27, 2010
- Report Date
- February 3, 2011
- Manufacturer
- INTEGRA LIFESCIENCES CORP. (INTEGRA-OHIO)
- Product Code
- HBL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
THE REPORTER STATED THAT DURING A BUNION SURGERY PROCEDURE, THE PT'S BONE WAS CRACKED WHILE THE SURGEON WAS ADVANCING THE TRAILING HEAD OF THE SCREW. STAPLES WERE USED AS A TEMPORARY FIXATION. THE PT REPORTED MORE POSTOPERATIVE PAIN THAN IS USUAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STANDARD KOMPRESSOR SCREW 20 MM | KOMPRESSOR COMPRESSION SCREW SYSTEM | HBL | INTEGRA LIFESCIENCES CORP. (INTEGRA-OHIO) | 8340208714J9 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |