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

Model Number	108-107-01-SC
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned with a fractured tip, confirming the event.No radiographs or images identifying the location of the tip were provided.The material yielded/fractured at the base of the hexalobe tip which is indicative of high torsional force.The device otherwise meets dimensional specifications except for the fractured tip.No patient injury reported with this event.Unknown factors include: patient bone quality (sclerotic bone), use of proper instrumentation (use of taps), or level of force (excessive torsional force).Surgery was completed without further incident.There is no evidence to suggest a manufacturing or design defect has occurred.
Event or Problem Description
While driving the pedicle bone screw and reportedly burying it into sclerotic bone, surgeon heard a pop.The driver tip fractured and remained in the head of the screw shank.Though the driver tip was identified, the surgeon elected to leave the driver tip and the screw in place.No injury to the patient or future injury anticipated.

• 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: 9218563
• Report Number: 3004893332-2019-00009
• Device Sequence Number: 2230828
• Product Code: NKB
• UDI-Device Identifier: 00840916134778
• UDI-Public: 00840916134778
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2019

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: 108-107-01-SC
• Device Lot Number: 190197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 103