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

Model Number	47000-065-050
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned implant is currently under investigation.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
During revision surgery for an unrelated event, the tulips of two polyaxial screw were discovered broken.Additionally, while performing the xlif of the l2-l3, it was also noticed neither set screws in l3 were threaded.Surgeon decided to finish patient and then flip and revise the existing hardware.Got everything 100 percent explanted for revision down to l5.Because a full revision had become necessary, the case was extended greater than 30 minutes.The arsenal spinal fixation system was originally implanted on (b)(6) 2017.
Additional Manufacturer Narrative
An evaluation of both the polyaxial screws revealed the tulip exit bores are visibly out of round indicating that the shank sphere deformed the material as it exited the bottom of the tulip.There was no damage or disassembly of the internal bushing component on either screw.However, one of the screws shanks showed wear marks at the neck indicative of a tulip that was at the max angulation permissible per the design.The threads on the second polyaxial screw retained a part of set screw material; indicating that the failure was due to a high axial load at that level.The evidence indicates that both polyaxial screws failed due to an axial load where the shank exited the bottom of the tulip.Additionally, one of the set screws displayed a starburst pattern wear mark on bottom surface; this wear mark indicates set screw back out due to repetitive loading.The starburst pattern is indicative of a non-normal loading of the rod under a dynamic loading conditions.The second set screw also contained the starburst pattern wear mark in addition to thread fracture.Thread fracture is a static failure that results from increased load on minimal thread engagement.This failure can be a resultant of the set screw back out; resulting in less thread engagement.

• 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: 9873957
• Report Number: 2027467-2020-00020
• Device Sequence Number: 560890
• Product Code: NKB
• UDI-Device Identifier: 00844856070752
• UDI-Public: (01)00844856070752(10)8017202
• 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: 2017
• 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): 02/25/2020

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: 47000-065-050
• Device Catalogue Number: 47000-065-050
• Device Lot Number: 8017202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 05/15/2020
• 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: Other
• Patient Age: 25 YR