FDA Adverse Event
Injury
Summary report: N
MOSS VRS
MDR report key: 21365014
·
Received February 12, 2025
Report
- Report Number
- 8010944-2025-00001
- Event Type
- Injury
- Date Received
- February 12, 2025
- Report Date
- February 12, 2025
- Manufacturer
- BIEDERMANN MOTECH GMBH & CO. KG
- Product Code
- NKB
- UDI-DI
- 4250869655521
- PMA / PMN Number
- K203607
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE FOLLOWING DEVICE ARE INVOLVED: 1. 3X 108-017-0001 MOSS VRS TI REDUCTION HEAD POLYAXIAL / BATCH BD21GSM, 2. 3X 108-004-0003 MOSS VRS TI LOCKING CAP XT ISR25 / BATCH BD2R7SC, 2X BD2R2SB, 3. 2X 107-018-6040 MOSS TI PEDICLE SCREW Ø6.0X40MM, DL, POLYAXIAL, LIGHT GREEN / BATCH BD2V2SH, 4. 1X 107-018-6045 MOSS TI PEDICLE SCREW Ø6.0X45MM, DL, POLYAXIAL, LIGHT GREEN / BATCH BD2R3SE.
Description of Event or Problem · 0
AFTER A DEFORMITY SURGERY IT WAS DISCOVERED DURING FOLLOW-UP THAT THE BOTTOM THREE SCREWS OF THE CONSTRUCT WERE LOOSE. THE INVESTIGATION OF THE THREE PEDICLE SCREWS AND SET SCREWS SHOWED THAT THE CONSTRUCT WAS NOT FULLY TIGHTENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1043385 | MOSS VRS | MOSS VRS TI REDUCTION HEAD POLYAXIAL | NKB | BIEDERMANN MOTECH GMBH & CO. KG | BD21GSM | 4250869655521 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |