FDA Adverse Event
Injury
Summary report: N
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
MDR report key: 11613812
·
Received April 5, 2021
Report
- Report Number
- 3006179046-2021-00219
- Event Type
- Injury
- Date Received
- April 5, 2021
- Report Date
- June 21, 2021
- Manufacturer
- NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
- Product Code
- PGN
- UDI-DI
- 00812258026318
- PMA / PMN Number
- K171791
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
NO DEVICE EVALUATION CAN BE PERFORMED AS IT IS IMPOSSIBLE TO TRACK THE DEVICE. CLINICAL X-RAYS WERE PROVIDED BY THE CUSTOMER WHICH INDICATED A BROKEN PIN IN THE ROD. DEVICE HISTORY REVIEW (DHR) WAS PERFORMED ON LOT NUMBER: A141007-21 AND THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS AND THE FINISHED PRODUCT MET ALL ACCEPTANCE CRITERIA PRIOR TO SHIPMENT.
Description of Event or Problem · 0
NO NEW INFORMATION PROVIDED.
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS CURRENTLY IN PROGRESS; A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON THE COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED IN (B)(6) 2021 DUE TO PIN BREAKAGE AND DISLODGEMENT, CAUSING THE ROD NOT TO FUNCTION PROPERLY. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 511906 | MAGEC SPINAL BRACING AND DISTRACTION SYSTEM | GROWING ROD SYSTEM - MAGNETIC ACTUATION | PGN | NUVASIVE SPECIALIZED ORTHOPEDICS, INC. | MS1-5590S | A141007-21 | 00812258026318 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Hospitalization| R |