MAUDE Adverse Event Report: PRECISION SPINE, INC. REFORM TI MODULAR; DOMINO CONNECTOR

Model Number	39-DA-1201
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation - other; distributor.Evaluation was not possible as the product was not returned to the manufacturer.Review of device history records found (b)(4) pieces of this lot were released for distribution on 6/17/2020 with no deviation or anomalies.Two-year complaint history review found this to be the only report of this nature for this part number.Should the product be received, a follow-up medwatch report will be submitted upon completion of investigation.
Event or Problem Description
It was reported that the patient underwent initial implantation on (b)(6) 2020, utilizing the reform pedicle screw system.Subsequently the patient presented with pain and a revision procedure was performed on (b)(6) 2021.It was noted that the parallel domino, closed-open, wide ((b)(4)) was loose.The rods, lock-screws, cross connector and dominos were removed and replaced.The original pedicle screws remain implanted.

• Brand Name: REFORM TI MODULAR
• Common Device Name: DOMINO CONNECTOR
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 11263165
• Report Number: 3005739886-2021-00007
• Device Sequence Number: 14578394
• Product Code: KKY
• UDI-Device Identifier: 00840019938471
• UDI-Public: 00840019938471
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/06/2021

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: Health Professional
• Device Model Number: 39-DA-1201
• Device Catalogue Number: 39-DA-1201
• Device Lot Number: 00117CV
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 02/01/2021
• 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; Required Intervention