FDA Adverse Event
Injury
Summary report: N
UNKNOWN 9MM TUNNELOC
MDR report key: 3193552
·
Received June 27, 2013
Report
- Report Number
- 0001825034-2013-02345
- Event Type
- Injury
- Date Received
- June 27, 2013
- Date of Event
- May 29, 2013
- Report Date
- May 31, 2013
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- MBI
- PMA / PMN Number
- PUNKNOWN
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED PATIENT UNDERWENT AN ANTERIOR CRUCIATE LIGAMENT TIBIAL PROCEDURE ON (B)(6) 2012. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO THE TUNNELOC HAD BACKED OUT AND WAS SITTING ON THE TIBIA IN A VERTICAL POSITION. THE TUNNELOC WAS REMOVED AND NO IMPLANT WAS USED AS THE ACL HAD HEALED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 294476 | UNKNOWN 9MM TUNNELOC | FASTENER, FIXATION | MBI | BIOMET ORTHOPEDICS | N/A | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |