FDA Adverse Event
Other
Summary report: N
OSTEOMED LDA CANNULATED SCREWS
MDR report key: 865775
·
Received June 14, 2007
Report
- Report Number
- 2027754-2007-00007
- Event Type
- Other
- Date Received
- June 14, 2007
- Date of Event
- March 1, 2007
- Report Date
- June 14, 2007
- Manufacturer
- OSTEOMED L.P.
- Product Code
- HWC
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- DPM
Narratives
Additional Manufacturer Narrative · 1
PROD NOT RETURNED - GIVEN TO PT. COULD BE LACK OF MEDULLARY BONE PURCHASE OR EXCESS PT ACTIVITY, ALTHOUGH NO INDICATION PT WAS NON-COMPLIANT. ADD'L MODEL# IS 319-2438.
Description of Event or Problem · 1
PT UNDERWENT FUSION OF TOE USING CANNULATED SCREWS. AT POST-OP VISIT 6 WEEKS LATER, PT COMPLAINED OF PAIN. SCREWS HAD BACKED OUT A FEW MM. BECAUSE FUSION HAD OCCURRED, DR REMOVED SCREWS FROM PT. PAIN WAS RELIEVED. PT DOING FINE. NO INDICATION PT WAS NON-COMPLIANT. POSSIBLE TIP OF SCREW WAS NOT PLACED IN MEDULLARY BONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OSTEOMED LDA CANNULATED SCREWS | CANNULATED SCREWS | HWC | OSTEOMED L.P. | 319-2442 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |