FDA Adverse Event
Malfunction
Summary report: N
DISPOSABLE CEMENT SCULPS
MDR report key: 3033748
·
Received April 3, 2013
Report
- Report Number
- 0001811755-2013-00690
- Event Type
- Malfunction
- Date Received
- April 3, 2013
- Date of Event
- March 6, 2013
- Report Date
- March 6, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON EVALUATION WEAR WAS OBSERVED ON THE SCULPS.
Additional Manufacturer Narrative · 1
A FOLLOW UP REPORT WILL BE FILED WHEN THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION HAS BEEN COMPLETED. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT BLUE FLAKES WERE SEEN WHEN USING THE DISPOSABLE CEMENT SCULP TO SCRAPE. THE FLAKES DID NOT COME IN CONTACT WITH THE SURGICAL SITE. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.
Description of Event or Problem · 1
IT WAS REPORTED THAT BLUE FLAKES WERE SEEN WHEN USING THE DISPOSABLE CEMENT SCULP TO SCRAPE. THE FLAKES DID NOT COME IN CONTACT WITH THE SURGICAL SITE. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 135771 | DISPOSABLE CEMENT SCULPS | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT. | LXH | STRYKER INSTRUMENTS-KALAMAZOO | 13040012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |