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

Model Number	108-SS
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent plif spinal fusion surgery (l5-s1) on (b)(6) 2021 to correct grade 3 spondylolisthesis and pain.Two weeks post operatively it was discovered that the left l5 lock screw had loosened.Revision surgery to replace the screw with a larger screw occurred on (b)(6) 2022.
Additional Manufacturer Narrative
Radiographs received confirmed the event.Returned devices were dimensionally measured and found to be in specification.Torque handle was tested and was in specification.Subject device was visually evaluated and marring of the bottom of the set screw that was in contact with the rod, suggests loosening and instability.Final tightening of the lock screw cannot be confirmed from the markings on the bottom of the set screw.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability 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 is unknown.

• Brand Name: OVERWATCH
• Common Device Name: 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: 13549446
• Report Number: 3004893332-2022-00003
• Device Sequence Number: 17424624
• Product Code: NKB
• UDI-Device Identifier: 00840916131234
• UDI-Public: (01)00840916131234(10)201765(11)210526
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 108-SS
• Device Catalogue Number: 108-SS
• Device Lot Number: 201765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 84 KG