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

Model Number	108-L-8580
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient is reported to be asymptomatic.No product will be returned as it remains in-situ, no product information was given, and no further evaluation of the product can be completed at this time.Radiograph received depicting fracture of both inferior-most screws.Patient reportedly has a high bmi.Patient compliance with postop care is unknown.Contraindications include, but are not limited to: obesity.An overweight or obese patient can produce loads on the spinal system which can lead to failure of the fixation of the device or to failure of the device itself.Possible adverse effects: potential adverse effects may include, but are not limited to the following: bending, disassembly, or fracture of any or all implant components.
Event or Problem Description
In (b)(6) 2018, the patient presented for a revision surgery of a prior lumbar fusion with instrumentation (l3-s1) from another manufacturer.Both s1 screws in that construct had reportedly fractured.In the revision procedure, the prior construct was removed and overwatch instrumentation was implanted in its' place (from l3 to s2, skipping s1).Approximately 90 days post-operatively, the two inferior-most screws were reported as fractured.Surgeon is monitoring the patient.

• Brand Name: OVERWATCH
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• MDR Report Key: 8465707
• Report Number: 3004893332-2019-00004
• Device Sequence Number: 1436292
• Product Code: NKB
• UDI-Device Identifier: 00840916130398
• UDI-Public: 00840916130398
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2019

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 Model Number: 108-L-8580
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR