MAUDE Adverse Event Report: NUVASIVE, INC. PRECEPT; INTERNAL SPINAL FIXATION PROCEDURE KIT, SINGLE-USE

Model Number	8801069
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when the surgeon inserted screw at s2ai, the screw was deviated although the guide wire used.He tried remove the screw, but the guide wire fractured.The fragment of the wire remained into the body and bleeding occurred.The surgeon interrupted surgery and transferred the patient to the angiography room.After that, the planed surgery was canceled.A revision surgery occurred on (b)(6) 2026.The surgeon removed the fragment of the wire and completed spinal fixation.The fragment of wire removed was discarded.No adverse effect reported following the revision.
Additional Manufacturer Narrative
The device is unavailable for evaluation.The root cause cannot be determined at this time.A supplemental report will be submitted upon receipt of additional information to support this investigation.

• Brand Name: PRECEPT
• Common Device Name: INTERNAL SPINAL FIXATION PROCEDURE KIT, SINGLE-USE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• 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: 24966609
• Report Number: 2031966-2026-00059
• Device Sequence Number: 10496611
• Product Code: LXH
• UDI-Device Identifier: 00887517346964
• UDI-Public: 00887517346964
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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: 8801069
• 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: 04/22/2026
• Initial Report FDA Received Date: 04/23/2026
• 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 Sex: Female