FDA Adverse Event
Injury
Summary report: N
ECT NARROW SELF-COMPRESSION PLATE
MDR report key: 276494
·
Received May 5, 2000
Report
- Report Number
- 1822565-2000-00040
- Event Type
- Injury
- Date Received
- May 5, 2000
- Date of Event
- March 28, 2000
- Manufacturer
- ZIMMER, INC.
- Product Code
- HRS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
ON 2/4/2000 PT WAS ADMITTED TO THE HOSP FOLLOWING A MOTOR VEHICLE CRASH WITH AN OPEN FRACTURE OF THE RIGHT TIBIA. OPEN REDUCTION WITH INTERNAL FIXATION OF THE RIGHT TIBIA WITH PLACEMENT OF A COMPRESSION PLATE WAS PERFORMED. ON 3/28/2000 PT CONTACTED SURGEON'S OFFICE WITH REPORT OF PAIN IN RIGHT LEG FOLLOWING A SUDDEN, JERKING MOVEMENT WHILE PT WAS IN BED. ON 3/30/2000 PT HAD DIAGNOSTIC OFFICE VISIT WHICH REVEALED BREAKAGE OF PLATE. ON 3/31/2000 PT ADMITTED WITH FRACTURED RIGHT TIBIA WITH BREAKAGE OF THE PLATE WHICH REQUIRED REVISION SURGERY TO REMOVE AND REPLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECT NARROW SELF-COMPRESSION PLATE | SELF-COMPRESSION PLATE | HRS | ZIMMER, INC. | NA | 50616400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |