FDA Adverse Event
Malfunction
Summary report: N
OSTEOMED
MDR report key: 93756
·
Received May 27, 1997
Report
- Report Number
- 2027754-1997-00027
- Event Type
- Malfunction
- Date Received
- May 27, 1997
- Date of Event
- April 19, 1997
- Report Date
- May 23, 1997
- Manufacturer
- OSTEOMED CORP.
- Product Code
- DZH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
RECIP. SAW BENT DURING SURGERY. THEN BORK OFF AFTER COOL DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OSTEOMED | RECIP SAW | DZH | OSTEOMED CORP. | NA | 9650007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |