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

Model Number	47000-075-055
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No evaluation possible at this time.The implant has not been returned.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.
Event or Problem Description
A patient underwent a second revision surgery on (b)(6) 2020.The case was conducted because the patient had pseudoarthrosis and screws had loosened.While removing the loosened screw at the sacrum to replace it with new one, it was found broken.The proximal section was removed while distal portion, approximately 40mm remains impacted within the patient's sacrum.The event caused over a 30 minute delay in the case.The arsenal spinal fixation system was initially implanted on (b)(6) 2019 as a replacement and extension for a previously implanted zodiac construct.
Additional Manufacturer Narrative
The returned implant is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Additional Manufacturer Narrative
An evaluation of the returned polyaxial screw could not determine root cause.Under magnification, the fracture patterns exhibit two separate possible outcomes based on both the evidence and description of the event.1.Revision surgery was conducted because the patient had pseudoarthrosis and screws had loosed.This would be consistent with the pattern which has a large smooth flat surface with ridges where the crack spread likely under fatigue until failure occurred.2.When removing the loose screw at the sacrum, it was found broken.The second pattern displayed appears to be in a torn and ripped motion.The elevated high points are jagged, pointy and rough.This would likely be consistent with a difficult removal.Twisting, bending and prying in an attempt to extract the distal threaded portion which may have become entrapped by boney ingrowth throughout the 10 months of implantation.

• 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: 9780203
• Report Number: 2027467-2020-00015
• Device Sequence Number: 14150180
• Product Code: NKB
• UDI-Device Identifier: 00844856070998
• UDI-Public: (01)00844856070998(10)SM67038
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2020

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?: No
• Operator of Device: No Information
• Device Model Number: 47000-075-055
• Device Catalogue Number: 47000-075-055
• Device Lot Number: SM67038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 02/05/2020; 02/05/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 04/02/2020; 04/15/2020
• 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: Hospitalization; Other
• Patient Age: 79 YR