MAUDE Adverse Event Report: ALPHATEC SPINE INC SET SCREW (TI-6AL-4V ELI); PEDICLE SCREW SYSTEM

Model Number	47127
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted arsenal set screw is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
During 8 week post op visit, a review of the x-ray found one of the set screws had backed out of position.Revision surgery was conducted on (b)(6) 2019.The arsenal spinal fixation system was originally implanted on (b)(6) 2018 during a posterior lumber interbody fusion (plif) of the l4-5.
Additional Manufacturer Narrative
An investigation of the returned set screw showed that the threads are not deformed which indicates the set screw had not been cross threaded.However, an evaluation of the bottom set screw surface revealed unusual wear marks.The bottom surface is the surface which interacts with the rod to create a stable construct, therefore the wear pattern on this surface may be indicative of the screw performance.The expected set screw bottom surface pattern is as hour glass wear pattern resulting from a fully tightened set screw, normal to rod, with distributed loading of the rod.The explant set screws show wear marks that are unevenly distributed which indicates a non-normalized loading condition.Additionally, the mating rod does not exhibit the hour glass wear markings and instead contains a single wear mark along the length of the implant.The wear mark is indicative of a set screw failure mode in which slippage had transpired.Based on these findings, the explants indicate that set screw disengagement is a result of a non-distributed loading and non-normalized rod conditions at final lockdown.

• Brand Name: SET SCREW (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: 8331338
• Report Number: 2027467-2019-00002
• Device Sequence Number: 13699433
• Product Code: NKB
• UDI-Device Identifier: 00840967124582
• UDI-Public: (01)00840967124582
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2019

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: Health Professional
• Device Model Number: 47127
• Device Catalogue Number: 47127
• Device Lot Number: 8155201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 03/28/2019
• 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: 52 YR