FDA Adverse Event
Injury
Summary report: N
MITEK, CUFFTACK ANCHOR
MDR report key: 458074
·
Received May 6, 2003
Report
- Report Number
- 1221934-2003-00035
- Event Type
- Injury
- Date Received
- May 6, 2003
- Date of Event
- October 3, 2002
- Manufacturer
- MITEK WORLDWIDE
- Product Code
- MAI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
PATIENT UNDERWENT ARTHROSCOPIC RCR. THREE WEEKS LATER PATIENT HAD MARKED SUBACROMIAL CREPITUS AND MECHANICAL SYMPTOMS. REPEAT ARTHROSCOPY THREE WEEKS AFTER RCR SHOWED MULTIPLE CUFFTACK DEVICES HAD SHEARED OFF IN SUBACROMIAL SPACE. REVISION RCR PERFORMED AND HARDWARE WAS REMOVED. (PER PHONE CONVERSATION WITH THE REP.: THE RE-OPERATION FOR REMEDIAL ACTION WAS SUCCESSFUL AND WAS CONCLUDED USING OTHER ARTHROSCOPIC MEANS........AFRIGAULT 04/14/2003 10:05:10 AM)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MITEK, CUFFTACK ANCHOR | FIXATION DEVICE | MAI | MITEK WORLDWIDE | 251120 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |