MAUDE Adverse Event Report: PRECISION SPINE, INC. REFORM PEDICLE SCREW SYSTEM; SCREWDRIVER

Model Number	39-SP-0730
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 lot number - unknown d4 primary unique device identifier - unknown without lot identification.H4 device manufacture date - unknown without lot identification h3 device evaluation - without the ability to examine the complaint product, no conclusions can be drawn.Without lot identification, manufacturing history and lot specific complaint history review is not possible.Two-year complaint history review did not reveal a trend for reports of this nature for the reported part number.Should the complaint product be received, a follow-up medwatch will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that during a procedure was performed on (b)(6) 2025, utilizing the reform pedicle screw system.While attempting to insert an unknown screw, the tip of thet20 polyaxial driver reform pedicle screw system (39-sp-0730) broke and subsequently when trying to remove the screw the driver broke again.Subsequently, when attempting to insert the second screw using the retention bone-screwdriver (39-sp-0601) the screw broke.Additional details have been requested.
Additional Manufacturer Narrative
H3 device evaluation: visual evaluation of the broken driver notes the driver tip in the has a planar fracture plane indicating failure due to torsional overload.The polyaxial driver's fracture is in agreement with the tip in the non-fractured screw assembly indicating torsional overload.Reported information notes difficulty properly placing the screws and screw breakage during repositioning and removal.The cause for the failures is believed to be related to the difficulties involved in the screw placement, repositioning, and removal, and the torsional and/or torsional and bending moment loads applied in attempts to properly seat and/or remove the screws.Review of device history records found five (5) pieces of lot 17609ps released for distribution on 1/7/2022 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for the reported part number.No corrective actions are recommended at this time.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2025, utilizing the reform pedicle screw system.Surgeon noted the one of the screws was incorrectly position and during attempts to remove it, the tip of the retention bone-screw driver (39-sp-0601) broke.A small rod was inserted into the screw and the entire screw was successfully removed using a strong rod holder.The surgeon then attempted to reposition and reinsert the same screw.However, it remained incorrectly placed and required removal.During the removal attempt the head of the reform 8.5 x 70mm polyaxial pedicle screw (39-pa-8570) fractured.The screw was ultimately extracted using a rod.The screw head broke completely off during the final stage of removal.While inserting a new screw, the tip of the polyaxial driver assembly reform pedicle screw system (39-sp-0730) broke.A rod was used to remove the screw as the driver tip was stuck in the screw head, and the procedure was successfully completed without further issue.There was a five (5) minute delay to the procedure as a result of the issues reported.

• Brand Name: REFORM PEDICLE SCREW SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC.; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive drive; pearl, MS 39208 ; 6014224244
• MDR Report Key: 22045601
• Report Number: 3005739886-2025-00007
• Device Sequence Number: 8880258
• Product Code: HXX
• UDI-Device Identifier: 00840019900515
• UDI-Public: (01)00840019900515(11)220107(10)39540PS
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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
• Device Model Number: 39-SP-0730
• Device Catalogue Number: 39-HP-0730
• Device Lot Number: 39540PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2022
• 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
• Patient Sex: Unknown