MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MAGEC SPINAL BRACING AND DISTRACTION SYSTEM; ORTHOPEDIC INTERNAL FIXATION SYSTEMS, SPINAL

Model Number	MS1-4590S
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation.Radiographs provided did not confirm the alleged event.No root cause can be confirmed at this time.
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2020.As per reporter, the patient did not lengthen during multiple attempts over the last year.Reportedly, the rods may be jammed and did not reach their maximum distraction length.
Additional Manufacturer Narrative
Investigation findings: the rod was received for visual and functional testing.Visual inspection revealed score marks observed on the distraction rod.Functionality testing revealed that the rod was unable to distract with manual distractor and the electronic remote controller (erc).The rod was unable to retract with fast distractor to perform stroke test per.Due to the current condition of the rod (not functional), force testing was not performed.The reported failure mode was confirmed as the rod was failed to distract and it did not meet acceptance test specifications per.The rod was sectioned and debris build up was found, which may have caused the reduced functionality.Sectioning of the rod determined that it could not be separated from the housing without use of high force.Bending forces applied to the rod from patient anatomy/activity may have caused the distraction rod to wedge into the housing tube, which would cause the rod to be jam.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.
Event or Problem Description
This report has been updated to include investigation findings.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Common Device Name: ORTHOPEDIC INTERNAL FIXATION SYSTEMS, SPINAL
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• MDR Report Key: 9757163
• Report Number: 3006179046-2020-00117
• Device Sequence Number: 3308016
• Product Code: PGN
• UDI-Device Identifier: 00812258026295
• UDI-Public: 812258026295
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K171791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MS1-4590S
• Device Lot Number: A160620-02
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 YR