FDA Adverse Event
Malfunction
Summary report: N
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
MDR report key: 17731915
·
Received September 12, 2023
Report
- Report Number
- 3006179046-2023-00338
- Event Type
- Malfunction
- Date Received
- September 12, 2023
- Report Date
- November 2, 2023
- Manufacturer
- NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
- Product Code
- PGN
- UDI-DI
- 00887517944313
- PMA / PMN Number
- K201543
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL DATA: B5, D4 (MODEL NUMBER AND UDI NUMBER), H10. LOT NUMBER 910722 WAS PROVIDED, HOWEVER, THIS IS AN INVALID LOT NUMBER AS IT APPEARS TO BE MISSING A DIGIT.
Additional Manufacturer Narrative · 0
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.
Description of Event or Problem · 0
ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Description of Event or Problem · 0
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO THE ROD NOT LENGTHENING AFTER MULTIPLE ATTEMPTS. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1146454 | MAGEC SPINAL BRACING AND DISTRACTION SYSTEM | GROWING ROD SYSTEM - MAGNETIC ACTUATION | PGN | NUVASIVE SPECIALIZED ORTHOPEDICS, INC. | MC2-4590R | UNKNOWN | 00887517944313 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Prefer Not To Disclose |