MAUDE Adverse Event Report: PRECISION SPINE, INC. REFORM TI CT MODULAR MIS PEDICLE SCREW SYSTEM; ROD INSERTER

Model Number	64-RD-9010
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information - unknown.Other serious (important medical events) - retained foreign object due to the broken tip of the inserter being left under the tightened rod component implanted in the patient.Initial reporter occupation - other; sales representative.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2022, utilizing the reform mis ct pedicle screw system.When tightening down on one of the lock screws for the second rod inserted, the tip of the rod inserter assembly reform mis (39-rd-9010) broke.The doctor continued tightening down on the rod leaving the broken inserter tip locked under the rod.There was no delay to the procedure.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2022, utilizing the reform mis ct pedicle screw system.When tightening down on one of the lock screws for the second rod inserted, the tip of the rod inserter assembly reform mis (39-rd-9010) broke.The doctor continued tightening down on the rod leaving the broken inserter tip locked under the rod.There was no delay to the procedure.6.Relevant tests/laboratory data, including.
Additional Manufacturer Narrative
H3 device evaluation - the rod inserter was returned with the tip broken off and not included with the part.The cause for the breakage cannot be ascertained from the complaint but based upon prior functional assessments medial-lateral loading conditions are suspected as the likely cause.Review of device history records found thirty-three (b)(4) of lot 18513fr were released for distribution on 5/21/2021 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.No corrective actions are being recommended.Tip design modifications have been incorporated to improve resistance to breakage.The reported lot was manufactured prior to these design modifications.

• Brand Name: REFORM TI CT MODULAR MIS PEDICLE SCREW SYSTEM
• Common Device Name: ROD INSERTER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive dr; pearl, MS 39208 ; 6014204244
• MDR Report Key: 15958933
• Report Number: 3005739886-2022-00039
• Device Sequence Number: 5229488
• Product Code: LXH
• UDI-Device Identifier: 00840019942515
• UDI-Public: 00840019942515
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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: 64-RD-9010
• Device Catalogue Number: 64-RD-9010
• Device Lot Number: 18513FR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown