FDA Adverse Event
Injury
Summary report: N
TI QUARTER-TUBULAR PLATE WITH COLLAR 6 HOLES/47MM
MDR report key: 1820584
·
Received August 26, 2010
Report
- Report Number
- 2520274-2010-00159
- Event Type
- Injury
- Date Received
- August 26, 2010
- Report Date
- August 5, 2010
- Manufacturer
- SYNTHES (USA)
- Product Code
- HRS
- PMA / PMN Number
- PREAMEND
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED. MANUFACTURE SITE AND MANUFACTURE DATE CANNOT BE DETERMINED WITHOUT A LOT NUMBER. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.
Description of Event or Problem · 1
TWO (2) TI QUARTER-TUBULAR PLATES WITH COLLAR 6 HOLES/47MM WERE IMPLANTED IN A SIX YEAR OLD PT. ONE WAS PLACED ON THE RADIUS AND ONE ON THE ULNA. ONE MONTH LATER THE PT WAS RETURNED TO THE OPERATING ROOM FOR REMOVAL OF ONE BENT PLATE AND ONE BROKEN PLATE. THIS REPORT IS #1 OF 2 FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TI QUARTER-TUBULAR PLATE WITH COLLAR 6 HOLES/47MM | TUBULAR PLATE | HRS | SYNTHES (USA) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Required Intervention | SCREWS |