FDA Adverse Event
Other
Summary report: N
MATRYX INTEFERENCE SCREW
MDR report key: 856780
·
Received May 25, 2007
Report
- Report Number
- 9613278-2007-00021
- Event Type
- Other
- Date Received
- May 25, 2007
- Report Date
- April 27, 2007
- Manufacturer
- CONMED LINVATEC BIOMATERIALS LTD
- Product Code
- MAI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
Narratives
Additional Manufacturer Narrative · 1
WE WILL NOT RECEIVE THE IMPLANT BACK, SO WE CAN NOT MAKE ANY INVESTIGATION OR CONCLUSIONS.
Description of Event or Problem · 1
THE SCREW WAS STRIPPED BUT WAS ABLE TO BE USED. NO PATIENT INJURY, NO DEBRIS IN PATIENT. NO DELAY IN SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MATRYX INTEFERENCE SCREW | BIOABSORBABLE INTERFERENCE SCREW | MAI | CONMED LINVATEC BIOMATERIALS LTD | S0002895 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | NK |