FDA Adverse Event
Other
Summary report: N
BIO-PUSHLOCK 4.5MM X 18.5MM
MDR report key: 1001409
·
Received February 20, 2008
Report
- Report Number
- 1220246-2008-00030
- Event Type
- Other
- Date Received
- February 20, 2008
- Date of Event
- January 31, 2008
- Report Date
- January 31, 2008
- Manufacturer
- ARTHREX, INC.
- Product Code
- MAI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A ROTATOR CUFF PROCEDURE (RIGHT SHOULDER) THE PEEK EYELETS DETACHED FROM THE DEVICE. THE SURGEON HAD PLACED 4 STRANDS OF SUTURE AND AFTER TAPPING DOWN THE PUSHLOCK, HE HEARD A POP. WHEN THE DEVICE WAS PULLED OUT, THE EYELET HAD COME OUT (X2). SURGEON USED A THIRD ONE FROM A DIFFERENT LOT, DEEPER INTO THE BONE AND COMPLETED THE CASE SUCCESSFULLY. NO FURTHER PT INFO IS AVAILABLE FROM CUSTOMER. THIS DEVICE IS USED FOR TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIO-PUSHLOCK 4.5MM X 18.5MM | BIO-ABSORBABLE IMPLANT | MAI | ARTHREX, INC. | NA | 142185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |