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

Model Number	108-L-6540
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient is reportedly stable other than reported symptoms.No revision is planned at this time.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 right inferior-most screw.Patient reportedly has a high bmi.Patient compliance with postop care is unknown.If healing is delayed, or does not occur, the implant may eventually loosen, bend or break.Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant.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
On (b)(6) 2018, the patient underwent posterior lumbar interbody fusion surgery with instrumentation (l2-s1).On (b)(6) 2019 it was discovered that the right s1 screws in that construct had reportedly fractured.Patient exhibits bilateral lower extremity numbness and tingling.No revision surgery is planned and the surgeon will continue to monitor.

• 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: 8596456
• Report Number: 3004893332-2019-00005
• Device Sequence Number: 2169787
• Product Code: NKB
• UDI-Device Identifier: 00840916129989
• UDI-Public: 00840916129989
• 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): 04/19/2019

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-6540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 92