FDA Adverse Event
Malfunction
Summary report: N
C-TEK MAXAN IMPLANTS
MDR report key: 1381768
·
Received May 15, 2009
Report
- Report Number
- 2242816-2009-00032
- Event Type
- Malfunction
- Date Received
- May 15, 2009
- Date of Event
- April 27, 2009
- Report Date
- May 6, 2009
- Manufacturer
- EBI, LLC
- Product Code
- KWQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL PRODUCT INFORMATION;CATALOG NUMBER LOT NUMBER MFG DATE14-521616 566170 11/200814-521616 598170 11/200814-521616 835270 03/2009THE DHRS WERE REVIEWED FOR ALL PARTS AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
SCREW WAS IMPLANTED AND NEEDED TO BE REPOSITIONED; HOWEVER, SCREW WOULD NOT COME OUT. SCREW AND PLATE WERE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | C-TEK MAXAN IMPLANTS | 2- LEVEL 28MM PLATE | KWQ | EBI, LLC | 13272J |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |