MAUDE Adverse Event Report: PRECISION SPINE, INC. REFORM TI HA COATED PEDICLE SCREW; BONE SCREW

Model Number	39-HT-7535
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information - unknown.Lot number - unknown.Occupation - other; distributor.Device manufacture date - unknown without lot identity.Device evaluation - evaluation is not possible as the screw was discarded at the hospital.Investigation is limited to the information provided along with complaint history.Two-year complaint history review found this to be the only report of this nature for any part number in the reform ti pss ha coated screw family.No conclusions can be drawn as to the cause of the reported loosening.This report is number 3 of 4 mdrs filed for the same event (reference 3005739886-2021-00055 / 00058).
Event or Problem Description
It was reported that the patient underwent a procedure on (b)(6) 2021, in which reform ti pedicle screw system product was implanted.Subsequently, it was identified that at least one of the pedicle screws was noted to be loose and a revision procedure was performed on (b)(6) 2021, in which three (3) of the (4) screws implanted were remove and replaced with a competitor's screws.During the revision procedure when attempting to remove one of the previously torqued lock screws, the tip of the lock-screw torque driver (39-rd-0060) broke off.The tip was removed, and the procedure successfully completed utilizing the second driver, readily available in the set.Screws removed were discarded at the hospital.As it is unknown which of the three screws removed were loose, all three are being reported.

• Brand Name: REFORM TI HA COATED PEDICLE SCREW
• Common Device Name: BONE SCREW
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 12691190
• Report Number: 3005739886-2021-00057
• Device Sequence Number: 4445113
• Product Code: KWP
• UDI-Device Identifier: 00815362029190
• UDI-Public: 00815362029190
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K151422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/30/2021

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-HT-7535
• Device Catalogue Number: 39-HT-7535
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/25/2021
• 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: Required Intervention