FDA Adverse Event
Malfunction
Summary report: N
DUET SUTURE ANCHOR
MDR report key: 954189
·
Received April 24, 2007
Report
- Report Number
- 9613278-2007-00017_2
- Event Type
- Malfunction
- Date Received
- April 24, 2007
- Report Date
- April 10, 2007
- Manufacturer
- CONMED LINVATEC BIOMATERIALS LTD
- Product Code
- MAI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
WE HAVE NOT YET RECEIVED THE IMPLANT BACK. WE WILL FOLLOW-UP THIS REPORT ACCORDINGLY AFTER EVAL.
Description of Event or Problem · 1
CUSTOMER WENT TO USE THE PRODUCT (IMPLANTED) AND NOTICED AFTER THAT THE THREADS ARE STRIPPED. NO INJURIES INVOLVED. NO DELAYS. AN ANOTHER ITEM USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUET SUTURE ANCHOR | BIOABSORBABLE SOFT TISSUE FIXATION | MAI | CONMED LINVATEC BIOMATERIALS LTD | * | S0002759 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |