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

Model Number 108-ET-6550C

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

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 08/03/2021

Event Type  Injury  

Manufacturer Narrative

Photos and ct images confirmed the complaint.Patient retains explanted screws and no evaluation can be completed.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 or 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 but duration to failure could be a contributing factor.

Event Description

On (b)(6) 2020 patient received bilateral posterior fixation from l2- s1.One year post operatively the patient felt pain.Ct depicted both screws at s1 were fractured and patient was revised on (b)(6) 2021 and both screws were replaced.Patient is asymptomatic post revision surgery.

• 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: 12387963
• MDR Text Key: 268804611
• Report Number: 3004893332-2021-00010
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00840916131876
• UDI-Public: (01)00840916131876(10)192477(11)200418
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 108-ET-6550C
• Device Catalogue Number: 108-ET-6550C
• Device Lot Number: 192477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2020
• 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
• Patient Age: 63 YR
• Patient Weight: 108