FDA Adverse Event
Injury
Summary report: N
CONMED LINVATEC SPECTRUM
MDR report key: 2013468
·
Received March 4, 2011
Report
- Report Number
- MW5019691
- Event Type
- Injury
- Date Received
- March 4, 2011
- Date of Event
- March 4, 2001
- Report Date
- March 4, 2011
- Manufacturer
- CONMED LINVATEC
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DR (B)(6) WAS PERFORMING A RIGHT SHOULDER ARTHROSCOPY/BANKHART PROCEDURE. HE WAS USING A CONMED LINVATEC SPECTRUM 45 DEGREE TO THE LEFT HOOK, REFERENCE (B)(4) WHEN APPROXIMATELY 1 CM. OF THE TIP BROKE OFF IN THE PATIENT'S RIGHT CAPSULE. DR (B)(6) WAS ABLE TO RETRIEVE THE TIP UNDER FLUOROSCOPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONMED LINVATEC SPECTRUM | 45 DEGREE TO THE LEFT SUTURE HOOK | LXH | CONMED LINVATEC | 97.14115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Disability |