MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM TI PEDICLE SCREW SYSTEM; MODULAR BONE SCREW

Model Number	39-SB-6545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent tlif l5-s1 to address degenerative disc disease on (b)(6) 2022.Subsequently, during routine follow-up it was noted that one ø6.5mm x 45mm reform ti modular non-cannulated screw (39-sb-6545) and one ø6.5mm x 50mm reform ti modular non-cannulated screw (39-sb-6550) had broken.An alif l5-s1 revision was performed on (b)(6) 2022, during which the broken screws were partially removed (distal portion of shank was inaccessible) from s1 with another screw placed.The patient indicates no trauma occurred.
Additional Manufacturer Narrative
H3 device evaluation - two screws with fractures propagating from the root of the threads (minor diameter) were returned along with a non-fractured screw.All returned modular screws were assembled to mating modular tulips.The two fractured screws were sent out for sem assessment (scanning electron microscope imaging).The results of the analysis indicate the failures were via fatigue.Both screws showed multiple crack origination locations at surface scratch marks.Both fracture locations were between 0.50" and 0.60" below the tulip's bottom surface, and roughly 0.50" below the screw necks.Based upon the sem findings and the need for a subsequent alif procedure backed up with screws indicates that fusion had not occurred, and that some instability was likely present.Review of device history records found twenty-four (24) pieces of this lot released for distribution on 8/31/2020 with no deviation or anomalies.Two-year complaint history review (5.30.2021-5.30.2023) found this to be the only report of this nature for the reform ti modular family of screws.No corrective actions are recommended.This report is number 1 of 2 mdrs filed for the same event (reference 3005739886-2023-00023).

• Brand Name: REFORM TI PEDICLE SCREW SYSTEM
• Common Device Name: MODULAR BONE SCREW
• 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: 17052840
• Report Number: 3005739886-2023-00022
• Device Sequence Number: 7067371
• Product Code: KWP
• UDI-Device Identifier: 00840019931953
• UDI-Public: 00840019931953
• 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
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2023

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: 39-SB-6545
• Device Catalogue Number: 39-SB-6545
• Device Lot Number: 31985PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2020
• 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: 48 YR
• Patient Sex: Male