MAUDE Adverse Event Report: ALPHATEC SPINE INC ARSENAL SPINAL FIXATION SYSTEM; PEDICLE SCREW SYSTEM

Model Number	47127
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned implants are currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
Existing zodiac construct of the l4-s1 was extended one level (l3) with the arsenal fixation system on (b)(6) 2019.1 week following the fusion, the patient heard a pop sound while stretching his back.X-rays were ordered found the left l3 setscrew had disassociated itself from the l3 pedicle screw.Revision surgery took place on (b)(6) 2019 to remove and replace both the arsenal set screw and pedicle screw at the l3 with the zodiac.
Additional Manufacturer Narrative
Investigation of the set screw showed that the threads are not deformed which indicates that set screw was not cross threaded.However, the set screw bottom surface showed unusual wear marks.The bottom surface of the set screw is the surface that interacts with the rod to create a stable construct, therefore the wear pattern on this surface may be indicative of the screw performance.The explant set screw does not exhibit the hour glass wear mark.This indicates a non-distributed or normalized loading condition at lock down.Furthermore, the set screw showed wear marks similar to a starburst pattern which indicates set screw back out due to repetitive loading.This starburst pattern being indicative of a non-normal loading of the rod under a dynamic loading conditions.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: ARSENAL SPINAL FIXATION SYSTEM
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad, ca
• MDR Report Key: 9694199
• Report Number: 2027467-2020-00007
• Device Sequence Number: 1877550
• Product Code: NKB
• UDI-Device Identifier: 00840967124582
• UDI-Public: (01)00840967124582(10)8272904
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 01/15/2020

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?: Yes
• Operator of Device: No Information
• Device Model Number: 47127
• Device Catalogue Number: 47127
• Device Lot Number: 8272904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/03/2020
• 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