MAUDE Adverse Event Report: CHOICESPINE, LLC GIBRALT SPINAL SYSTEM; GIBRALT POLYAXIAL SCREW 3.5X28MM

Model Number	05-000-20-3528
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The case was a revision of a previous posterior cervical fusion in which the gibralt screws were used.The surgeon thought it was odd that the screw was breaking half way up the thread, inside the bone.Xrays were reviewed prior to incision.

• Brand Name: GIBRALT SPINAL SYSTEM
• Common Device Name: GIBRALT POLYAXIAL SCREW 3.5X28MM
• Manufacturer (Section D): CHOICESPINE, LLC; 400 erin drive; knoxville TN 37919
• Manufacturer (Section G): CHOICESPINE, LLC; 400 erin drive; knoxville TN 37919
• Manufacturer Contact: tracy huling ; 400 erin drive; knoxville, TN 37919 ; 8652433967
• MDR Report Key: 12905874
• Report Number: 3005819474-2020-00003
• Device Sequence Number: 16661875
• Product Code: KWP
• UDI-Device Identifier: 10885862145055
• UDI-Public: 10885862145055
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K110197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/19/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 05-000-20-3528
• Device Catalogue Number: 05-000-20-3528
• Device Lot Number: 38796010
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 53 YR
• Patient Sex: Male