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

Model Number RA002-4545SL

Device Problems Break (1069); Degraded (1153); Structural Problem (2506); Failure to Advance (2524); Appropriate Term/Code Not Available (3191); Physical Resistance/Sticking (4012)

Patient Problem Failure of Implant (1924)

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation.Radiographs provided confirmed the alleged event.No root cause can be confirmed at this time.

Event Description

Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter, x-rays revealed a pin break.Reportedly, the patient had been struck across the back with a wooden pole.During the removal, bone had fused around the rod and the surgeon had to use a small mallet to encourage the rod to move and loosen.Once removed, it was noted that there was positioning /movement in the rod.

Event Description

An investigation report from an implant retrieval center was received and reported that during examination of the rod, the retrieval center found that the rod exerted no force during force testing.The leadscrew was seized inside the extending bar and both components were also covered in debris.The drive pin was reported to be broken an the o-ring had snapped.Consequently, it may have been unable to seal effectively.No additional information is available.

Manufacturer Narrative

Evaluation was performed by newcastle engineering lab.A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.If any additional information is provided, a supplemental report will be submitted.

Manufacturer Narrative

Corrected h6 device code.

Event Description

No additional information provided.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: ORTHOPEDIC INTERNAL FIXATION SYSTEMS, SPINAL
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• Manufacturer Contact: tiara rae ; 101 enterprise; suite 100; aliso viejo, CA 92656 ; 6197314188
• MDR Report Key: 9747852
• MDR Text Key: 182910869
• Report Number: 3006179046-2020-00114
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00856719002183
• UDI-Public: 856719002183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2023

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
• Device Operator: Health Professional
• Device Model Number: RA002-4545SL
• Device Lot Number: A131004-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 02/01/2023; 02/01/2023
• Supplement Dates FDA Received: 02/10/2023; 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR
• Patient Sex: Male