MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
Report
- Report Number
- 3006179046-2022-00168
- Event Type
- Malfunction
- Date Received
- April 13, 2022
- Report Date
- June 27, 2022
- Manufacturer
- NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
- Product Code
- PGN
- UDI-DI
- 00887517834041
- PMA / PMN Number
- K171791
- 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.
ADDITIONAL DATA: B5, D4, G3, G6, H2, G6, H10.
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: MC2-5090S LOT NUMBER 9052408 MC2-5090R LOT NUMBER 8122112.
CORRECTED DATA: D4, G4 ADDITIONAL DATA: B5, D9, G3, G6, H2, H3, H6, H10. COMPLAINT 1 OF 2. VISUAL INSPECTION OF THE RETURNED MAGEC ROD REVEALED THAT THE ROD WAS PARTIALLY DISTRACTED WITH SOME WEAR/SCORE MARKS CONSISTENT WITH EXPECTED MARKINGS DUE TO INCREMENTAL DISTRACTION. THE WEAR/SCORE MARKS OBSERVED ON THE DISTRACTION ROD WOULD INDICATE THE DISTRACTION ROD WAS EXTENDED APPROXIMATELY 7.00 MM FROM ITS INITIAL POSITION. X-RAY IMAGES OF THE INTERNAL COMPONENTS SHOWED NO DAMAGE AND REVEALED THE ROD WAS PARTIALLY DISTRACTED. THE LENGTH OF THE ROD WAS MEASURED AT 267.10 MM. THE ROD WAS FUNCTIONALLY TESTED AND WAS ABLE TO DISTRACT AND RETRACTOR WITH THE MANUAL DISTRACTOR AS WELL AS THE EXTERNAL REMOTE CONTROLLER (ERC). THE MINIMAL AND MAXIMUM LENGTHS WERE MEASURED AT 261.84 MM AND 308.90 MM RESPECTIVELY, GIVING A TOTAL STROKE MEASUREMENT OF 47.06 MM, WHICH MEETS THE SPECIFICATION. THE REPORTED FAILURE MODE WAS UNABLE TO BE CONFIRMED, AS THE ROD WAS FULLY FUNCTIONAL AND MET ACCEPTANCE TEST SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DISCREPANCIES RELATED TO THIS COMPLAINT. THE ROD WAS MANUFACTURED IN ACCORDANCE WITH THE SPECIFIED REQUIREMENTS AND MET ALL OF THE REQUIRED QUALITY INSPECTIONS.
INFORMATION WAS RECEIVED THAT THE ROD WOULD NOT DISTRACT. NO PATIENT ADVERSE EVENT WAS REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED.
ADDITIONAL INFORMATION WAS RECEIVED.
NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 708723 | MAGEC SPINAL BRACING AND DISTRACTION SYSTEM | GROWING ROD SYSTEM - MAGNETIC ACTUATION | PGN | NUVASIVE SPECIALIZED ORTHOPEDICS, INC. | MC2-5090S | 9052408BAB | 00887517834041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Prefer Not To Disclose |