MAUDE Adverse Event Report: ALPHATEC SPINE INC TI ALLOY STRAIGHT ROD, 5.5 MM X 500 MM (TI-6AL-4V ELI); PEDICLE SCREW SYSTEM

Model Number	48001-55-500
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned arsenal construct is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
Patient bent over and rod popped out of position.Revision surgery was conducted on (b)(6) 2017 to remove and replace the arsenal construct.The arsenal spinal fixation system was originally implanted on (b)(6) 2017.
Additional Manufacturer Narrative
The entire construct was explanted and care taken to identify the location of each explanted pedicle screw and set screw.After examining the product under a microscope, the following wear characteristics were noted as unique to the product identified at the levels where set screw back-out occurred: witness marks on the 30° surface of both the polyaxial screw and set screw buttress threads."starburst" pattern on the distal surface of the set screw.The wear patterns noted on the affected product are indicative of a binding condition between the set screw and the mating polyaxial screw.It is possible to replicate this binding condition when the set screw is final tightened on a rod that is not fully normalized in the polyaxial screw.The binding condition leads to insufficient transfer of torque to the axial clamping force on the rod which may result in set screw back-out.

• Brand Name: TI ALLOY STRAIGHT ROD, 5.5 MM X 500 MM (TI-6AL-4V ELI)
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad CA 92008
• MDR Report Key: 6570135
• Report Number: 2027467-2017-00028
• Device Sequence Number: 13745735
• Product Code: NKB
• UDI-Device Identifier: 00844856072848
• UDI-Public: 00844856072848
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K133221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2017

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: Physician
• Device Model Number: 48001-55-500
• Device Catalogue Number: 48001-55-500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2017
• Supplement Report FDA Received Date: 06/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 68 YR