FDA Adverse Event
Injury
Summary report: N
CHRONOS BETA-TCP STRIP-STERILE
MDR report key: 1820559
·
Received August 26, 2010
Report
- Report Number
- 2939274-2010-00011
- Event Type
- Injury
- Date Received
- August 26, 2010
- Report Date
- August 5, 2010
- Manufacturer
- NORIAN CORPORATION
- Product Code
- MQV
- PMA / PMN Number
- K071046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS ONGOING, NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED. MANUFACTURE DATE HAS BEEN REQUESTED.
Description of Event or Problem · 1
A PT WAS IMPLANTED WITH HARDWARE AND CHRONOS STRIP WITHOUT COMPLICATIONS. THE PT WAS RETURNED TO THE OPERATING ROOM FOR REMOVAL OF SCREWS DUE TO INFECTION OF THE TISSUE. THE INFECTION AREA WAS VERY SIMILAR TO THE AREA WHERE THE STRIP HAS BEEN PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHRONOS BETA-TCP STRIP-STERILE | CHRONOS STRIPS | MQV | NORIAN CORPORATION | NA | N992800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |