FDA Adverse Event
Malfunction
Summary report: N
TC CRILE-WOOD NH 7 MATTE
MDR report key: 7448354
·
Received April 20, 2018
Report
- Report Number
- 2523190-2018-00059
- Event Type
- Malfunction
- Date Received
- April 20, 2018
- Date of Event
- March 29, 2018
- Report Date
- April 2, 2018
- Manufacturer
- INTEGRA YORK, PA INC.
- Product Code
- MDM
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, THEREFORE THE FAILURE MODE CANNOT BE CONFIRMED. THE ROOT CAUSE CANNOT BE DETERMINED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION.
Description of Event or Problem · 1
THIS REPORT IS 2 OF 2. A CUSTOMER REPORTED TO INTEGRA THAT A 123131 TC CRILE-WOOD NH 7 MATTE WAS USED ON (B)(6) 2018 DURING AN UNSPECIFIED PROCEDURE. IT WAS STATED THAT THE TIP OF SERRATION BROKE OFF INTRA-OPERATIVELY WHEN THE SURGEON USED A 3-0 NEEDLE WITH THE NEEDLE-HOLDER. ADDITIONAL INFORMATION RECEIVED ON 02APR2018 INDICATING THAT THE BROKEN PIECE WAS NOT RETRIEVED. THE DEVICE WAS IN CONTACT WITH THE PATIENT BUT NO PATIENT INJURY OR SURGERY DELAY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 289428 | TC CRILE-WOOD NH 7 MATTE | N/A | MDM | INTEGRA YORK, PA INC. | 102731 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |