MAUDE Adverse Event Report: SPINAL ELEMENTS, INC OVERWATCH; SOLID SCREW DRIVER

Catalog Number	108-107-01-S
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned device confirmed that the device is fractured and the distal tip is missing.The remains of the returned device were measured and met specifications.No images or objective evidence of the event were provided confirming the device tip was left in patient.Based on available information the event is likely the result of patient anatomy/ osteosclerotic bone (as reported) requiring excessive force and result of surgical technique (excessive force).Though no patient injury reported, the instrument and its tip are a non surgical grade (non implantable) stainless steel, is not suitable for implantation (possible long-term consequence) and is not intended to remain in the patient.
Event or Problem Description
On (b)(6) 2026 patient underwent revision surgery to remove hardware for spinal fusion surgery for adjacent segment disease after successful fusion had occurred at index level.Reportedly due to the patient's sclerotic bone and bone ingrowth, the bone screw was fused to the bone.Intra-operatively excessive force was use and the bone screwdriver device fractured at the tip.The surgeon elected to leave the bone screw and the device tip encased in the screw head and completed the procedure.

• Brand Name: OVERWATCH
• Common Device Name: SOLID SCREW DRIVER
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• Manufacturer (Section G): SPINAL ELEMENTS; 3115 melrose dr; carlsbad CA 92010
• Manufacturer Contact: peter perhach ; 3115 melrose dr; carlsbad, CA 92010
• MDR Report Key: 25124977
• Report Number: 3004893332-2026-00003
• Device Sequence Number: 10694351
• Product Code: LXH
• UDI-Device Identifier: 00840916134686
• UDI-Public: (01)00840916134686(10)250857(11)250922
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K191576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

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 Catalogue Number: 108-107-01-S
• Device Lot Number: 250857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown