FDA Adverse Event
Injury
Summary report: N
BC DISTRACT-BODY END ACTIV DISTRACTION-L
MDR report key: 2926035
·
Received January 23, 2013
Report
- Report Number
- 2520274-2013-00539
- Event Type
- Injury
- Date Received
- January 23, 2013
- Date of Event
- August 19, 2012
- Report Date
- December 28, 2012
- Manufacturer
- SYNTHES (USA)
- Product Code
- MQN
- PMA / PMN Number
- K060138
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.
Description of Event or Problem · 1
A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A PROCEDURE, A DISCONNECTION OF THE EXTRACTION ARM COULD NOT BE ACHIEVED. THE DISTRACTOR WAS EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE. THIS IS 1 OF 4 REPORTS FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 32929 | BC DISTRACT-BODY END ACTIV DISTRACTION-L | BC DISTRACT-BODY | MQN | SYNTHES (USA) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | DISTRACT-BODY, MESH FOOT, LOCKING SCREW |