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
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2022, in australia, utilizing the reform ti mis ct modular percutaneous screw system.Upon final tightening of one of the set screws, the modular polyaxial tulip assembly reform mis pedicle screw system (39-mt-0403) slowly moved up off of the screw and out of the patient.The screw was then removed, and a second screw and tulip were assembled and implanted with no further issue.There was a slight (a few minutes) delay to the procedure because of this malfunction, but no patient injury was reported.
Additional Manufacturer Narrative
Patient information - unknown.Occupation - other; distributor.Type of reportable event - assessed as a serious injury due to medical intervention required to remove and replace the pedicle screw following the malfunction of the modular tulip.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, in australia, utilizing the reform ti mis ct modular percutaneous screw system.Upon final tightening of one of the set screws, the modular polyaxial tulip assembly reform mis pedicle screw system (39-mt-0403) slowly moved up off of the screw and out of the patient.The screw was then removed, and a second screw and tulip were assembled and implanted with no further issue.There was a slight (a few minutes) delay to the procedure because of this malfunction, but no patient injury was reported.
Additional Manufacturer Narrative
H3: device evaluation: the modular tulip and screw were provided in an assembled state.No visible irregularities were ascertained, and the assembly remains securely fixed together which is indicative of the design intent.No further assessment of this part is planned.Functional assessment of other parts from this lot was not feasible since no tulips from this lot were available.The implant design was subsequently reviewed and compared to the predicate reform ti modular tulip design (39-mt-040x) upon which this design is based.This predicate design has been in use for nearly 3 years without the noted failure.Both designs share the same design configuration, and same bone screw assembly characteristics.Parts were subsequently pulled from another lot and functional assessments performed to try to reproduce the failure.No instance of disassembly of a fully assembled screw occurred.Based upon all of the above, the observed condition is likely due to improper screw - tulip assembly, and no corrective actions are being recommended at this time.

• 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 dr; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive dr; pearl, MS 39208 ; 6014204244
• MDR Report Key: 15041697
• Report Number: 3005739886-2022-00022
• Device Sequence Number: 6943350
• Product Code: NKB
• UDI-Device Identifier: 00840019940610
• UDI-Public: 00840019940610
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

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-MT-0403
• Device Catalogue Number: 64-MT-0403
• Device Lot Number: 38854PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2022
• 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: 06/22/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2021
• 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 Sex: Unknown