FDA Adverse Event
Other
Summary report: N
BI-SWIVELOCK C 5.5MM X 15MM, CLOSED EYELET
MDR report key: 1032959
·
Received April 22, 2008
Report
- Report Number
- 1220246-2008-00068
- Event Type
- Other
- Date Received
- April 22, 2008
- Date of Event
- March 17, 2008
- Report Date
- March 27, 2008
- Manufacturer
- ARTHREX, INC.
- Product Code
- MAI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED, AND THE COMPLAINT COULD NOT BE VERIFIED. REVIEW OF THE DEVICE HISTORY REVEALED NOTHING RELEVANT TO THIS EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE CAUSE OF THE COMPLAINANT'S EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE AND WITHOUT DEVICE EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT A BLUE PIECE OF THE DEVICE CAME OFF IN THE PT'S SOFT TISSUE AND WAS LOST. THE PIECE COULD NOT BE RETRIEVED FROM THE PT. NO FURTHER PT INFO IS AVAILABLE AND NO ADD'L ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BI-SWIVELOCK C 5.5MM X 15MM, CLOSED EYELET | BIO-ABSORBABLE FIXATION DEVICE | MAI | ARTHREX, INC. | NA | 119686 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other |