MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	10000690
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Rupture (2208); Insufficient Information (4580)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a nuvasive torque wrench fractured during surgery resulting in extended surgery time and tissue trauma.This event occurred in germany.
Additional Manufacturer Narrative
The device has not 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 Manufacturer Narrative
The investigation revealed that the complaint was unable to be confirmed with the information provided and the root cause is unable to be determined.The event description notes there was ¿increased tissue trauma¿ and need for extended surgery which supports classification of event as serious.There was no reported permanent health consequences or impact to the patient.The device was not returned for evaluation, and no photographs were provided so the complaint could not be confirmed.No associated torque handle information was provided, and no information on the final lock screw driver used was provided.Although no definitive root cause could be determined, review of the reported event and similar events suggests excessive force and or fatigue failure after repeated high torque use over time as the likely cause or contributor.The fractured tip was recovered, and the case was able to continue and finish after removing the construct.Manufacturing review: no lot code information was provided on the so a complete manufacturing review could not be completed.Although review of ncmr records and similar events notes no non-conformances with respect to material type, treatments or dimensions that may have caused or contributed to this mode of failure.Labeling review was conducted with outcome of no deviations or impact to event noted.Risk evaluation: review of the complaint and associated risk document found the effects potentially related to the reported event have been identified and mitigated and the severity of possible effects do not exceed those estimated in the risk documentation.A review of confirmed past complaints identified reports of reline final lock screw drivers fracturing intraoperatively, at an occurrence rate lower than the estimated risk documentation associated with this product.No new harm event or adverse trend identified with the reported event.Additionally, based on the risk level estimated for this product, this complaint does not justify the need for new or additional risk evaluation.The product is within the anticipated risk; therefore, the overall risk of the system has been maintained and will continue to be monitored.
Event or Problem Description
It was reported that a nuvasive torque wrench fractured during surgery resulting in extended surgery time and tissue trauma.This event occurred in germany.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 22883646
• Report Number: 2031966-2025-00112
• Device Sequence Number: 8861364
• Product Code: NKB
• UDI-Device Identifier: 00887517497352
• UDI-Public: 887517497352
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: GM
• PMA/510(K) Number: K223181
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: 10000690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Female