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

Model Number 39-HT-6540

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2021

Event Type  Injury  

Manufacturer Narrative

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 1 of 4 mdrs filed for the same event (reference 3005739886-2021-00055 / 00058).

Event 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
• Type of Device: BONE SCREW
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive dr; pearl, MS 39208 ; 6014204244
• MDR Report Key: 12691126
• MDR Text Key: 278371237
• Report Number: 3005739886-2021-00055
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00815362029138
• UDI-Public: 00815362029138
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 39-HT-6540
• Device Catalogue Number: 39-HT-6540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention