MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM TI CT MODULAR MIS PEDICLE SCREW SYSTEM; MODULAR MIS EXTENDED TAB TULIP

Model Number	64-MT-0403
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2026.During placement of a 7.5 x 40mm modular screw (39-sk-7540) with an attached ct tulip (64-mt-0403), the attendant commented that although she was turning the screwdriver (75-rt-1750), she did not feel/observe advancement.It was then that the precision spine engineer looked at the position of the assistant's hands and noted their left hand was contacting the knob on the screwdriver that is used to attach/detach the screwdriver from the implant.From this it was surmised that this may have caused the screw to loosen from the driver, and he made her aware as such.She then removed the screw and driver from the patient and confirmed that this was the case.The implant was then re-tightened to the screwdriver before proceeding to re-insert into the s1 pedicle.Soon afterwards, it was commented from either the surgeon or the assistant that something did not feel right with the re-insertion of the screw implant.The driver was again removed from the patient, this time only the tulip was attached to the driver; the bone screw remained in the patient.A series of fluoroscopic images was taken to locate the position of the missing screw in the patient.An attempt of approximately 20 minutes was made to retrieve the screw but without success.The surgeon then proceeded to continue the surgery placing all necessary screws, cage, allograft, rods, etc., with the intent of performing an o-arm spin afterwards to help locate and extract the missing screw.The approximately 20-minute attempt to retrieve the screw after the o-arm spin was also not successful.The patient was then sutured closed with the missing screw not recovered.It was relayed in a telephone conversation the next day that the patient had underwent another procedure during which the missing screw was located and successfully removed.
Additional Manufacturer Narrative
H3 other - evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
Additional Manufacturer Narrative
H3 device evaluation - engineering evaluation noted the tulip's screw interface end was visually examined with the aid of a 10x loop.Gross deformation of the ring or the tulip's bottom surface is not present.Mechanical testing of screws attached to tulips exhibit gross deformation for screw disassociation to occur.A bone screw was subsequently assembled to the tulip.Proper assembly was achieved.The bone screw - tulip assembly was subsequently tightened onto a screwdriver.No issues were encountered and the screw- tulip assembly function per the design intent.Based upon the above and the issues noted in the information provided it is believed that the scrub tech who assembled the screw to the tulip did not do so properly.Review of device history records found sixty-four (64) pieces of lot 52668ps released for distribution on 7/31/2025 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.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2026.During placement of a 7.5 x 40mm modular screw (39-sk-7540) with an attached ct tulip (64-mt-0403), the attendant commented that although she was turning the screwdriver (75-rt-1750), she did not feel/observe advancement.It was then that the precision spine engineer looked at the position of the assistant's hands and noted their left hand was contacting the knob on the screwdriver that is used to attach/detach the screwdriver from the implant.From this it was surmised that this may have caused the screw to loosen from the driver, and he made her aware as such.She then removed the screw and driver from the patient and confirmed that this was the case.The implant was then re-tightened to the screwdriver before proceeding to re-insert into the s1 pedicle.Soon afterwards, it was commented from either the surgeon or the assistant that something did not feel right with the re-insertion of the screw implant.The driver was again removed from the patient, this time only the tulip was attached to the driver; the bone screw remained in the patient.A series of fluoroscopic images was taken to locate the position of the missing screw in the patient.An attempt of approximately 20 minutes was made to retrieve the screw but without success.The surgeon then proceeded to continue the surgery placing all necessary screws, cage, allograft, rods, etc., with the intent of performing an o-arm spin afterwards to help locate and extract the missing screw.The approximately 20-minute attempt to retrieve the screw after the o-arm spin was also not successful.The patient was then sutured closed with the missing screw not recovered.It was relayed in a telephone conversation the next day that the patient had underwent another procedure during which the missing screw was located and successfully removed.

• Brand Name: REFORM TI CT MODULAR MIS PEDICLE SCREW SYSTEM
• Common Device Name: MODULAR MIS EXTENDED TAB TULIP
• 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: 24612136
• Report Number: 3005739886-2026-00012
• Device Sequence Number: 9834109
• Product Code: NKB
• UDI-Device Identifier: 00840019940610
• UDI-Public: (01)00840019940610(11)250725(1052668PS
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K150856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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-MT-0403
• Device Catalogue Number: 64-MT-0403
• Device Lot Number: 52668PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male