FDA Adverse Event
Injury
Summary report: N
INTERNAL MIDFACE DISTRACTOR, 35MM
MDR report key: 2915051
·
Received January 10, 2013
Report
- Report Number
- 8010177-2013-90009
- Event Type
- Injury
- Date Received
- January 10, 2013
- Date of Event
- December 18, 2012
- Report Date
- December 18, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- JEY
- PMA / PMN Number
- K092743
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT ONE SIDE OF THE PATIENT FAILED TO "DISTRACT" AND THAT THE ACTIVATION ARM HAD BECOME DETACHED. THE PATIENT'S PARENT HAD TRIED TO RE-APPLY THE ACTIVATION ARM BUT IT WOULD NOT STAY IN PLACE. THE BONE KNITTED TOGETHER AND THEREFORE THE PATIENT WAS REQUIRED TO UNDERGO AN ADDITIONAL PROCEDURE IN ORDER TO HAVE THEIR BONE RE-CUT. THE SECOND SURGERY WAS COMPLETED SUCCESSFULLY USING THE SAME ACTIVATION ARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 13972 | INTERNAL MIDFACE DISTRACTOR, 35MM | IMPLANT | JEY | STRYKER OSTEOSYNTHESIS FREIBURG | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |