FDA Adverse Event
Injury
Summary report: N
STRYKER INSTRUMENTS, INC
MDR report key: 536105
·
Received July 20, 2004
Report
- Report Number
- 536105
- Event Type
- Injury
- Date Received
- July 20, 2004
- Date of Event
- July 9, 2004
- Report Date
- July 20, 2004
- Manufacturer
- STRYKER INSTRUMENTS, INC
- Product Code
- LOD
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- MO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ADD'L INFO REC'D FROM MFR 9/14/04: STYKER INSTRUMENTS DID NOT SUBMIT A MEDICAL DEVICE REPORT FOR THIS INCIDENT. UPON FURTHER INVESTIGATION, THE REPORTING PHYSICIAN NOW BELIEVES THE BONE BENEATH THE DEVICE (CEMENT) WAS THE CAUSE OF THE FAILURE, NOT THE DEVICE (CEMENT). THEREFORE, IN ACCORDANCE WITH 803.22 (B)(1) A MEDICAL DEVICE REPORT WOULD NOT BE REQUIRED.
Description of Event or Problem · 1
MD'S STATED VERTEBROPLASTY IN 2004, PT RETURNED WITH PAIN, SURGERY REQUIRED THREE DAYS LATER. BONE CEMENT HAD TURNED TO POWDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRYKER INSTRUMENTS, INC | BONE CEMENT | LOD | STRYKER INSTRUMENTS, INC | 505-583-000 | 04176CS2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Hospitalization| R |