MAUDE Adverse Event Report: SPINAL ELEMENTS, INC OVERWATCH; PEDICLE SCREW DRIVER ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	108-157-01
Medical Device Problem Codes	Unintended System Motion (1430); Unintended Movement (3026)
Health Effect - Clinical Code	Vertebral Fracture (4520)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportedly during a tlif spinal fusion surgery with posterior fixation (l2- s1), a pedicle bone screw fractured/cracked the pedicle bone l3 on (b)(6) 2023.Allegedly the driver or driver sleeve was bent.The device wobbled and had a different trajectory and/or different starting point, when advancing the screw.This condition alleged caused a cracked/fracture in the pedicle bone.No additional medical intervention was taken.Patient is asymptomatic and there is no plan for revision surgery.
Additional Manufacturer Narrative
Unknown factors include: proper implant selection (size/diameter), health of the bone (strength or density), or omission of tools/surgical technique (omission of a tap).Additionally, no images of the anatomy were provided for analysis.Complaint cannot be confirmed.Root cause cannot be determined.

• Brand Name: OVERWATCH
• Common Device Name: PEDICLE SCREW DRIVER ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• Manufacturer Contact: peter perhach ; 3115 melrose dr; carlsbad, CA 92010
• MDR Report Key: 18340772
• Report Number: 3004893332-2023-00005
• Device Sequence Number: 15138476
• Product Code: OLO
• UDI-Device Identifier: 00840916134839
• UDI-Public: (01)00840916134839(10)211372(11)210909
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K222516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2023

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: 108-157-01
• Device Lot Number: 211372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown