MAUDE Adverse Event Report: SPINAL ELEMENTS, INC OVERWATCH; BONE TAP 4.5MM

Catalog Number	108-104-45
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026 patient underwent nine level posterior spinal fixation surgery.Reportedly due to the patient's sclerotic bone an under size 4.5mm bone tap was use to initiate the osteotomy.Intra-operatively the bone tap device fractured at the tip.The surgeon elected to leave the device tip encased in bone and complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
Evaluation of the device confirmed the device is fractured.The tip is missing from the device.No images of the event were provided confirming the device tip was left in patient.The root cause is likely the result of patient anatomy/ osteosclerotic bone (as reported) requiring excessive force and/or result of surgical technique (off axis redirection /excessive manipulation while advancing).The instrument and its tip are a non-surgical grade (non-implantable) stainless steel, is not suitable for implantation and is not intended to remain in the patient.The remains of the returned device were measured and met specification.

• Brand Name: OVERWATCH
• Common Device Name: BONE TAP 4.5MM
• 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: 24694367
• Report Number: 3004893332-2026-00002
• Device Sequence Number: 16069084
• Product Code: LXH
• UDI-Device Identifier: 00840916135331
• UDI-Public: (01)00840916135331(10)190093(11)190926
• 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): 03/26/2026

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: 108-104-45
• Device Lot Number: 190093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 68 YR
• Patient Sex: Male