FDA Adverse Event
Injury
Summary report: N
SKELETAL DYNAMICS
MDR report key: 10623420
·
Received October 2, 2020
Report
- Report Number
- 3006742481-2020-00009
- Event Type
- Injury
- Date Received
- October 2, 2020
- Date of Event
- September 3, 2020
- Report Date
- October 2, 2020
- Manufacturer
- SKELETAL DYNAMICS
- Product Code
- OZI
- UDI-DI
- 00841506104904
- PMA / PMN Number
- K153208
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO DEVICE PROBLEMS WERE IDENTIFIED. REVISION PROCEDURE WAS SUCCESSFULLY COMPLETED AND NO PROBLEMS HAVE BEEN IDENTIFIED. THE INSTRUCTIONS FOR USE FOR THE SYSTEM STATES: " IMPROPER PLACEMENT, POSITIONING, ALIGNMENT OR FIXATION OF THE IJS-E CONSTRUCT MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE COMPONENTS, CONSTRUCT FAILURE, POSTOPERATIVE COMPLICATIONS OR INEFFECTIVE TREATMENT."
Description of Event or Problem · 1
DETACHMENT OF CONNECTING ROD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1086648 | SKELETAL DYNAMICS | INTERNAL JOINT STABALIZER | OZI | SKELETAL DYNAMICS | IJS-E Base Plate Assembly | 00841506104904 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other |