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

Catalog Number 108-157-01

Device Problems Unintended System Motion (1430); Unintended Movement (3026)

Patient Problem Vertebral Fracture (4520)

Event Date 11/21/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 331049040
• Report Number: 3004893332-2023-00005
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00840916134839
• UDI-Public: (01)00840916134839(10)211372(11)210909
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1