FDA Adverse Event
Other
Summary report: N
BIO-TRANSFIX, 5MM X 40MM, LONG
MDR report key: 940129
·
Received April 13, 2007
Report
- Report Number
- 1220246-2007-00064
- Event Type
- Other
- Date Received
- April 13, 2007
- Date of Event
- March 14, 2007
- Report Date
- April 11, 2007
- Manufacturer
- ARTHREX, INC.
- Product Code
- MNU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION HAS BEEN INITIATED, BUT HAS NOT BEEN COMPLETED YET. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANT BROKE IN SEVERAL PARTS DURING THE SURGERY. THE DR DID NOT GET ALL THE PIECES, THEN USED A DRILL TO MAKE A HOLE FACILITATING THE ENTRANCE OF ANOTHER IMPLANT. IT IS NOT CLEAR FROM THE INFO AVAILABLE IF ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PT. ADD'L INFO HAS BEEN REQUESTED FROM THE FOREIGN DISTRIBUTOR. THIS DEVICE IS USED FOR TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIO-TRANSFIX, 5MM X 40MM, LONG | BIO-ABSORBABLE FIXATION DEVICE | MNU | ARTHREX, INC. | NA | 64067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |