FDA Adverse Event
Injury
Summary report: N
LOCKING CANNULATE BLADE PLATE
MDR report key: 10367666
·
Received August 5, 2020
Report
- Report Number
- 3006460162-2020-00085
- Event Type
- Injury
- Date Received
- August 5, 2020
- Date of Event
- July 8, 2020
- Report Date
- August 5, 2020
- Manufacturer
- ORTHOPEDIATRICS, CORP
- Product Code
- HRS
- PMA / PMN Number
- K110959
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REFERENCE: (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AN LCB PLATE WAS IDENTIFIED AS BROKEN 5-MONTHS POST-OPERATIVELY. CULTURES WERE TAKEN FOR POSSIBLE INFECTION. A REVISION SURGERY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 832302 | LOCKING CANNULATE BLADE PLATE | ORTHOPEDIC FIXATOIN PLATE | HRS | ORTHOPEDIATRICS, CORP | 00-1200-3505 | 176871-B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Required Intervention |