FDA Adverse Event
Injury
Summary report: N
SYNPLUG SIZE 16
MDR report key: 3760835
·
Received April 9, 2014
Report
- Report Number
- 2090010-2014-00020
- Event Type
- Injury
- Date Received
- April 9, 2014
- Date of Event
- November 19, 2013
- Report Date
- March 17, 2014
- Manufacturer
- ISOTIS ORTHOBIOLOGICS, INC
- Product Code
- LZN
- PMA / PMN Number
- K010840
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- 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
THIS IS THE FOURTH OF FOUR REPORTS CONCERNING THE SAME PT. THIS REPORT CONCERNS SYNPLUG SIZE 16 PRODUCT ID 804022. IT WAS REPORTED: 'ACCORDING TO THE RECEIVED COMPLAINT, THERE WAS A PERIFOCAL OSTEOLYSIS AT THE CEMENT PLUG. THE PT WAS ALSO EXPERIENCING WEAKENING OF THE BONE AND LOOSENING OF THE PROSTHESIS'. ADDITIONAL INFORMATION WAS REQUESTED BY INTEGRA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 212982 | SYNPLUG SIZE 16 | NONE | LZN | ISOTIS ORTHOBIOLOGICS, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |