FDA Adverse Event
Injury
Summary report: N
OPTIPLUG 16 - REF 4364
MDR report key: 3778180
·
Received April 16, 2014
Report
- Report Number
- 2090010-2014-00021
- Event Type
- Injury
- Date Received
- April 16, 2014
- Date of Event
- September 24, 2008
- Report Date
- March 21, 2014
- Manufacturer
- ISOTIS ORTHOBIOLOGICS, INC
- Product Code
- LZN
- PMA / PMN Number
- K010840
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem · 1
IT WAS REPORTED "THE PATIENT SUFFERED OF OSTEOLYSIS. A REVISION SURGERY IS SCHEDULED ON (B)(6) 2014. THE FIRST SURGERY OCCURRED ON (B)(6) 2003. NO ISSUE WERE DETECTED DURING MONITORING VISITS IN 2004 AND 2006. ON (B)(6) 2008, THE SURGEON NOTICED A SLIGHT OSTEOLYSIS ON CAP. A STEM FEMORAL LOOSENING OCCURRED. THE REVISION SURGERY IS PLANNED IN (B)(6). X-RAYS AND SURGICAL REPORT HAVE BEEN REQUESTED. "
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 234128 | OPTIPLUG 16 - REF 4364 | NA | LZN | ISOTIS ORTHOBIOLOGICS, INC | 111.385 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |