MAUDE Adverse Event Report: NUVASIVE, INCORPORATED GSB GLOBAL SPINAL BALANCE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	16016545
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation nor were x-ray films provided.Upon removal of screw, it was noticed distal tip of screw had splayed.As per reporter, both surgeon and intra-op ap fluoroscopy confirm screw did not come in contact with screws within anterior cage.Labeling review: ".Potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss of fixation, nonunion or delayed union, pain, discomfort or abnormal sensations due to the presence of the device." ".Warnings, cautions and precautions: internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break." ".Patient education:the patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen." ".Post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration well as to other complications.".
Event or Problem Description
Information was received patient underwent a revision procedure to place a smaller screw.It is unknown if patient was experiencing any symptoms.
Additional Manufacturer Narrative
Medwatch report # 2031966-2020-00133 was inadvertently submitted.After a review of the reported event, it has been determined that there no indication of an adverse reaction, death or serious injury, or the need for intervention to prevent death or serious injury.Further, death or serious injury is unlikely should this or a similar event recur.No reporting is required.
Event or Problem Description
See updated information in h10.

• Brand Name: GSB GLOBAL SPINAL BALANCE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 10198225
• Report Number: 2031966-2020-00133
• Device Sequence Number: 1019971
• Product Code: NKB
• UDI-Device Identifier: 00887517553584
• UDI-Public: 887517553584
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 16016545
• Device Lot Number: N240572
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1