FDA Adverse Event
Malfunction
Summary report: N
CALLOS 3CC INJECT
MDR report key: 1649836
·
Received March 30, 2010
Report
- Report Number
- 3003890476-2010-00001
- Event Type
- Malfunction
- Date Received
- March 30, 2010
- Date of Event
- February 23, 2010
- Report Date
- March 30, 2010
- Manufacturer
- SKELETAL KINETICS LLC
- Product Code
- MQV
- PMA / PMN Number
- K051123
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE MFR DOES NOT THINK THE EVENT WAS PRODUCT RELATED (CALLOS); THE LACK OF EFFECTIVENESS MOST LIKELY WAS RELATED TO PT CONDITION, IT WAS AN UNUSUAL EVENT.
Description of Event or Problem · 1
CALLOS HAD NO UNION AFTER 15 MONTHS. THE CALLOS WAS FRAGMENTED AND HARD BUT HAD NO UNION WITH THE BONE AND THE VDR PLATE. THE 2 MOST DISTAL ULNAR SCREWS BROKE WHERE THEY INTERFACE BETWEEN THE PLATE AND THE BONE. SURGEON HAD TO REMOVE ALL HARDWARE AND CALLOS, AND REPLACED WITH NEW PLATE AND DID AN ILIAC BONE GRAFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CALLOS 3CC INJECT | NONE | MQV | SKELETAL KINETICS LLC | #08061706 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |