FDA Adverse Event
Malfunction
Summary report: N
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
MDR report key: 11641238
·
Received April 9, 2021
Report
- Report Number
- 3006179046-2021-00226
- Event Type
- Malfunction
- Date Received
- April 9, 2021
- Date of Event
- March 15, 2021
- Report Date
- April 9, 2021
- Manufacturer
- NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
- Product Code
- PGN
- UDI-DI
- 00812258022662
- PMA / PMN Number
- K171791
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. IF ANY ADDITIONAL INFORMATION HAS BEEN PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED THAT DURING AN EXPLANT PROCEDURE FOR FINAL FUSION AFTER THE ROD HAD ACHIEVED ITS INTENDED PURPOSE, IT WAS NOTED THERE WAS A FRACTURE THROUGH THE ROD END CAP. NO PATIENT IMPACT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 537031 | MAGEC SPINAL BRACING AND DISTRACTION SYSTEM | GROWING ROD SYSTEM - MAGNETIC ACTUATION | PGN | NUVASIVE SPECIALIZED ORTHOPEDICS, INC. | MC2-5590S | 8060109 | 00812258022662 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR |