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

Model Number	62055-45
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The second screw part number/description which is reported to have also fractured and broke; 62040-30; polyaxial pedicle screw - 4.0mm x 30mm ((ti-6al-4v eli), lot# 641287.An evaluation is not possible at this time.The implant(s) have not been returned.Upon the receipt of additional information and/or the suspect implant(s) a follow report will be submitted.
Event or Problem Description
Alphatec legal received a product liability claim on april 15, 2020.The claim alleges that a patient whom previously had atec hardware installed ((b)(6) 2018) started to experience pain ((b)(6) 2018).On (b)(6) 2019, the surgeon determined she had broken screws and or hardware in her l4 vertebrae and revision surgery was necessary to remove and replace.The revision took place on (b)(6) 2019.

• Brand Name: ZODIAC LUMBAR SPINAL FIXATION SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad, ca
• MDR Report Key: 10055894
• Report Number: 2027467-2020-00024
• Device Sequence Number: 2916591
• Product Code: KWP
• UDI-Device Identifier: 00844856002944
• UDI-Public: (01)00844856002944(10)641696
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2020

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: 62055-45
• Device Catalogue Number: 62055-45
• Device Lot Number: 641696
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 05/14/2020
• 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
• Patient Age: 14 YR