MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
Report
- Report Number
- 3006179046-2022-00167
- Event Type
- Malfunction
- Date Received
- April 13, 2022
- Report Date
- June 27, 2022
- Manufacturer
- NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
- Product Code
- PGN
- UDI-DI
- 00812258026349
- PMA / PMN Number
- K201543
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
THE REPORTER PROVIDED THE MODEL AND LOT NUMBER OF TWO MAGEC RODS, BUT IT IS UNKNOWN WHICH OF THE TWO HAS THE REPORTED FAILURE TO DISTRACT. THE TWO RODS WERE REPORTED AS FOLLOWS: MS1-4570R LOT NUMBER A171016-03. MS1-4570S LOT NUMBER 0101446.
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
INFORMATION WAS RECEIVED THAT THE ROD WOULD NOT DISTRACT. NO PATIENT ADVERSE EVENT WAS REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED.
NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 653284 | MAGEC SPINAL BRACING AND DISTRACTION SYSTEM | GROWING ROD SYSTEM - MAGNETIC ACTUATION | PGN | NUVASIVE SPECIALIZED ORTHOPEDICS, INC. | MS1-4570R | A171016-03-1AM | 00812258026349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Prefer Not To Disclose |