MAUDE Adverse Event Report: SPINAL ELEMENTS, INC OVERWATCH; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 108-ET-6540C

Device Problems Fracture (1260); Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 02/03/2022

Event Type  Injury  

Event Description

As part of a retrospective review spanning 2019-2021 given by an orthopedic medical group, it was reported that a patient received a plf with bilateral posterior fixation from l5-s1.Revision surgery was performed on (b)(6) 2022.Photograph was provided of one of the s1 bone screws that fractured.No initial surgery information, patient information or event information were provided.

Manufacturer Narrative

Though revision surgery occurred, pathology department would not release device, and the devices were not returned.Device is not available for evaluation.Additionally, no event radiographs of the device were provided for analysis.Photo of the fractured screw confirmed the event.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, the longevity the degree of post lateral pseudarthrosis, patient compliance with post-operative care instructions or if the patient sustained a fall/impact of any sort (no trauma was reported).Root cause or specific failure mode cannot be determined.

• Brand Name: OVERWATCH
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• Manufacturer Contact: peter perhach ; 3115 melrose drive, suite 200; carlsbad, CA 92010 ; 7606071830
• MDR Report Key: 13660962
• MDR Text Key: 290459375
• Report Number: 3004893332-2022-00004
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00840916131852
• UDI-Public: (01)00840916131852(10)202351(11)201207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 108-ET-6540C
• Device Catalogue Number: 108-ET-6540C
• Device Lot Number: 202351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention