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

Model Number	47127
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Both the backed out set screw and mating polyaxial screw were explanted and returned for evaluation.The set screw investigation resulted in detection of wear marks on the bottom surface of the set screw that are not typical when compared to set screw wear marks of intended use.When used as intended the set screw will have symmetric marks.The explant set screw shows uneven marks, significantly deformed threads, and a "starburst" pattern (on half the set screw).The "starburst" wear pattern on the bottom surface of the set screw is indicative of motion between rod and screw.Therefore, the set screw disengagement may be attributed to repeated motion at the rod-screw interface resulting in set screw back out.Additional evaluation of the polyaxial screw resulted in detection of wear on the rod slot surfaces.The rod slot surfaces specifically contact the rod and the wear marks in the rod slot imply that there was motion between screw and rod.The motion is a result of non-locked down construct; which could be caused by non-normalization of the rod at final lockdown or user error.
Event or Problem Description
Revision surgery was conducted on (b)(6) 2019 to remove an arsenal set screw which had backed out approximately 6 months post-op.The arsenal spinal fixation system was originally implanted on (b)(6) 2018.

• 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: 8577967
• Report Number: 2027467-2019-00022
• Device Sequence Number: 1638652
• Product Code: NKB
• UDI-Device Identifier: 00840967124582
• UDI-Public: (01)00840967124582(10)8038401
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 04/12/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 47127
• Device Catalogue Number: 47127
• Device Lot Number: 8038401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/03/2019
• 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: Required Intervention
• Patient Age: 67 YR