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

Model Number 47127

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/24/2019

Event Type  Injury  

Manufacturer Narrative

The returned implants are currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.

Event 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.

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
• Type of Device: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad, ca
• MDR Report Key: 9694199
• MDR Text Key: 189168910
• Report Number: 2027467-2020-00007
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00840967124582
• UDI-Public: (01)00840967124582(10)8272904
• Combination Product (y/n): N
• PMA/PMN Number: K133221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization