FDA Adverse Event
Injury
Summary report: N
OSTEOMED PLATE MAXI CHIN
MDR report key: 107726
·
Received July 1, 1997
Report
- Report Number
- 107726
- Event Type
- Injury
- Date Received
- July 1, 1997
- Date of Event
- June 25, 1997
- Report Date
- June 26, 1997
- Manufacturer
- OSTEOMED CORPORATION
- Product Code
- HRS
- Report Source
- User Facility report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
BECAUSE OF NON-UNION OF ANTERIOR MANDIBLE AFTER SURGERY 6/4/97, PT RETURNED TO SURGERY 6/25/97 FOR REMOVAL OF PLATE AND IMPLANTATION OF A DIFFERENT PLATE. OSTEOMED PLATE AND SCREWS REMOVED AND KLS MARTIN PLATE AND SCREWS IMPLANTED. OSETOMED IMPLANTS TAKEN BY SURGEON. PER SURGEON; "FOUND OSTEOMED CHIN PLATE BENT STRAIGHT WITH CHIN DISPLACED INFERIORLY. REPOSITIONED CHIN SEGMENT AND STABILIZED WITH MORE RIGID KLS CHIN PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OSTEOMED PLATE MAXI CHIN Implant | BONE PLATE | HRS | OSTEOMED CORPORATION | 6MM | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention | ONE 202-2008 8MM, AND FOUR 202-2010 10MM| TWO OSTEOMED PLATE MINI 5 HOLE 30617, 210-0108,| OSTEOMED MINI-SCREW - SIX 202-2006 2.0X6MM, |