FDA Adverse Event
Injury
Summary report: N
OPUS MAGNUM IMPLANT
MDR report key: 548967
·
Received October 18, 2004
Report
- Report Number
- 2032380-2004-00002
- Event Type
- Injury
- Date Received
- October 18, 2004
- Date of Event
- June 23, 2004
- Manufacturer
- OPUS MEDICAL, INC.
- Product Code
- HTY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT RETURNED TO THE CLINIC POST-OP COMPLAINING OF PAIN AT NIGHT AND DURING OVERHEAD ACTIVITIES. THE SURGEON ORDERED AN ARTERIOGRAM WHICH SHOWED THAT THE MAGNUM IMPLANT MIGRATED OUT OF THE IMPLANT SITE AND INTO THE INTRACAPSULAR SPACE. ADDITIONALLY, A RE-TEAR OF THE ROTATOR CUFF WAS OBSERVED. THE SURGEON VIA A MINI-OPEN INCISION REMOVED THE LOOSE IMPLANT AND PERFORMED A REVISION OF THE REPAIR UTILIZING THE STANDARD TRANSOSSEOUS TUNNELING TECHNIQUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPUS MAGNUM IMPLANT | ORTHOPAEDIC BONE ANCHOR | HTY | OPUS MEDICAL, INC. | OM-1500 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Hospitalization| R |