MAUDE Adverse Event Report: PRECISION SPINE, INC SURELOK MINI POSTERIOR CERVICAL/UPPER; TAP

Model Number	04-9009-35
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 lot number - unknown d4 primary unique device identifier - full udi number is not available without lot identification h4 device manufacturing date - unknown without lot identification h3 device evaluation - without the opportunity to examine the complaint product, no conclusions can be drawn as to the root cause of the reported malfunction.Review of device history records and lot specific complaint history review are not possible without lot identification.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.No corrective actions are required.Should the product be received a follow-up report will be filed.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2025, utilizing the surelok posterior cervical system.During the final torque, the surgeon used the anti-torque tool on the screw head while tightening in the opposite direction of the nut.At that moment, the t-15 hexalobe torque driver (04-9097) broke.The broken piece was removed and the procedure continued.When attempting to use the tap to cut the thread for the screw with the desired size, it broke once it reached halfway into the screw's diameter, which was 12 mm and 3.5 mm in diameter.The broken part of the tap was easily removed from the patient.The surgical team proceeded by using a drill to complete the trajectory, and since one of the features of the posterior cervical screw is that it is self-tapping, the screw was able to engage and advance properly once the initial pathway was prepared.The procedure was completed with just a two minute delay and no harm to patient.
Additional Manufacturer Narrative
This submission is a corrected follow up report to mdr number 32005739886-2026-00008.The original mdr was submitted on 01/09/2026 but was later determined to have been submitted in error.During post submission review, it was identified that the initial mdr was triggered based on incomplete or misinterpreted information.Specifically, the original report incorrectly suggested that the device/event met mdr reporting criteria.Subsequent investigation confirmed that the event did not meet the threshold for reportability and therefore the original submission should be disregarded.The originally reported event did not involve a death, serious injury, or malfunction likely to result in serious injury or death if it were to recur.Updated investigation findings indicate that the original mdr trigger was based off complaint history for an incorrect part number.We respectfully request that the fda annotate the original mdr as "reported in error" and reference this corrected submission.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2025, utilizing the surelok posterior cervical system.During the final torque, the surgeon used the anti-torque tool on the screw head while tightening in the opposite direction of the nut.At that moment, the t-15 hexalobe torque driver (04-9097) broke.The broken piece was removed and the procedure continued.When attempting to use the tap to cut the thread for the screw with the desired size, it broke once it reached halfway into the screw's diameter, which was 12 mm and 3.5 mm in diameter.The broken part of the tap was easily removed from the patient.The surgical team proceeded by using a drill to complete the trajectory, and since one of the features of the posterior cervical screw is that it is self-tapping, the screw was able to engage and advance properly once the initial pathway was prepared.The procedure was completed with just a two minute delay and no harm to patient.

• Brand Name: SURELOK MINI POSTERIOR CERVICAL/UPPER
• Common Device Name: TAP
• 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 ; 6014204244
• MDR Report Key: 24028936
• Report Number: 3005739886-2026-00008
• Device Sequence Number: 8998204
• Product Code: HWX
• UDI-Device Identifier: 00840019920346
• UDI-Public: 00840019920346
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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
• Operator of Device: Health Professional
• Device Model Number: 04-9009-35
• Device Catalogue Number: 04-9009-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown