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

Model Number	48500-095-090
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/02/2020
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
Revision surgery was conducted on (b)(6) 2020 to remove pedicle which had fractured and broke just below the tulip/head.The arsenal deformity spinal fixation system was originally implanted on (b)(6) 2019.
Additional Manufacturer Narrative
An evaluation of the returned polyaxial screw could not determine root cause.It was confirmed that the implant was properly manufactured and released in accordance with design specifications.No manufacturing or processing related irregularities could be identified.It appears likely that the screw failure may be related to either the patient or unknown clinical factors/circumstances.The arsenal spinal fixation system is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.The arsenal system consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (ti-6al-4v eli).The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (cp ti grade 4, ti-6al-4v eli, and co-28cr-6mo).
Additional Manufacturer Narrative
D10: device availability - initially reported as no.Updated - yes with a return date of 05/04/2020.H6: event problem and evaluation codes - initially reported as 4114 product not returned.Updated - 11 conclusion not yet available.H10: additional narrative/data - initially reported as 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.Updated - the returned implant is currently under investigation.A follow up report with results of the investigation will be submitted upon completion.

• 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: 10092951
• Report Number: 2027467-2020-00027
• Device Sequence Number: 3342617
• Product Code: NKB
• UDI-Device Identifier: 00840967165776
• UDI-Public: (01)00840967165776(10)SM80460
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2020

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: Health Professional
• Device Model Number: 48500-095-090
• Device Catalogue Number: 48500-095-090
• Device Lot Number: SM80460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 04/30/2020; 04/30/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 06/08/2020; 08/14/2020
• 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