FDA Adverse Event
Malfunction
Summary report: N
SKELETAL DYNAMICS INC.
MDR report key: 19047820
·
Received April 4, 2024
Report
- Report Number
- 3006742481-2024-00004
- Event Type
- Malfunction
- Date Received
- April 4, 2024
- Date of Event
- March 5, 2024
- Report Date
- April 3, 2024
- Manufacturer
- SKELETAL DYNAMICS INC.
- Product Code
- OZI
- UDI-DI
- 00841506104904
- PMA / PMN Number
- K153208
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE INSTRUCTIONS FOR USE FOR THE IJS-E SYSTEM INCLUDES THE FOLLOWING WARNING: "FOR SAFE EFFECTIVE USE OF THE IMPLANT, THE SURGEON MUST BE THOROUGHLY FAMILIAR WITH THE SURGICAL TECHNIQUE FOR THE DEVICE, IMPLANT AND ASSOCIATED INSTRUMENTS. IMPROPER INSERTION OF THE DEVICE DURING IMPLANTATION MAY ALSO INCREASE THE POSSIBILITY OF LOOSENING, MIGRATION, AND FAILURE OF THE DEVICE OR THE TREATMENT." THE CONNECTING RODS MUST BE POSITIONED WITH THE MATING SPLINES FACING EACH OTHER IN ORDER TO FULLY TIGHTEN THE LOCKING SCREW. THIS WAS AN ERROR THAT THE SURGEON NOTICED DURING THE REVISION AND THEREFORE SHOULD HAVE NOTICED DURING THE INITIAL PROCEDURE.
Description of Event or Problem · 0
AN IMPLANTED IJS-E (INTERNAL JOINT STABILIZER - ELBOW) UNCOUPLED AT THE ARM JOINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 83189 | SKELETAL DYNAMICS INC. | IJS-E BASE PLATE ASSEMBLY | OZI | SKELETAL DYNAMICS INC. | 00841506104904 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Male | Required Intervention |