FDA Adverse Event
Malfunction
Summary report: N
SKELETAL DYNAMICS
MDR report key: 10299797
·
Received July 20, 2020
Report
- Report Number
- 3006742481-2020-00002
- Event Type
- Malfunction
- Date Received
- July 20, 2020
- Date of Event
- November 21, 2019
- Report Date
- January 8, 2020
- Manufacturer
- SKELETAL DYNAMICS
- Product Code
- OZI
- UDI-DI
- 00841506104904
- PMA / PMN Number
- K153208
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
VISUAL INSPECTION OF THE RETURNED DEVICE DID NOT DEMONSTRATE ANY OUT OF SPECIFICATION CONDITIONS. DAMAGE TO THE IMPLANT WAS CONSISTENT WITH OVER TORQUEING DURING IMPLANTATION. NO TRENDS HAVE BEEN IDENTIFIED AS OF THIS DATE BASED ON THE CURRENT DATA. EVIDENCE FOUND DURING THE INVESTIGATION POINTS TO A POSSIBLE OVER-TORQUEING DURING ASSEMBLY.
Description of Event or Problem · 1
THE PROXIMAL CONNECTING ROD OF THE IJS WAS BROKEN 6 WEEKS POST IMPLANTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 763877 | SKELETAL DYNAMICS | INTERNAL JOINT STABALIZER | OZI | SKELETAL DYNAMICS | IJS-E Base Plate Assembly | AN1811023 | 00841506104904 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other |