FDA Adverse Event
Other
Summary report: N
MANDIBULAR DISTRATOR PLATE
MDR report key: 384393
·
Received March 22, 2002
Report
- Report Number
- 1032347-2002-00004
- Event Type
- Other
- Date Received
- March 22, 2002
- Report Date
- March 20, 2002
- Manufacturer
- WALTER LORENZ SURGICAL, INC.
- Product Code
- MQN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
10 DAYS AFTER THE IMPLANTATION OF A DISTRACTOR PLATE, THE FLEXIBLE SHAFT COULD NOT DISTRACT THE DEVICE AS THE FORCE WAS TOO GREAT. THE DOCTOR THINKS THIS IS FROM THE EXCESSIVE FIBROUS TISSUE ON-GROWTH. A REVISION SURGERY WILL TAKE PLACE TO REPLACE THE FLEXIBLE SHAFT WITH A SOLID SHAFT TO CONTINUE THE DISTRACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANDIBULAR DISTRATOR PLATE | * | MQN | WALTER LORENZ SURGICAL, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |