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

Model Number 62055-45

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 01/29/2019

Event Type  Injury  

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 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
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): ALPHATEC SPINE INC; 5818 el camino real; carlsbad, ca
• Manufacturer Contact: richard younger ; 5818 el camino real; carlsbad, ca ; 4949286
• MDR Report Key: 10055894
• MDR Text Key: 191677335
• Report Number: 2027467-2020-00024
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00844856002944
• UDI-Public: (01)00844856002944(10)641696
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 62055-45
• Device Catalogue Number: 62055-45
• Device Lot Number: 641696
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 14 YR