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

Catalog Number	39-SK-6555
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an l4/l5/s1 procedure was performed on (b)(6) 2023, utilizing the reform ti modular cannulated pedicle screw system.Subsequently, the patient presented with pain and radiographical analysis showed compression of the construct and three (3) broken ø6.5mm x 55mm reform ti modular cannulated screws (39-sk-6555).A revision procedure was performed on (b)(6) 2024, during which all hardware was removed and replaced, with the exception of one side of l5 where tip portion of the broken screw remains.
Additional Manufacturer Narrative
H3- evaluation in process, not yet complete.A follow-up report will be filed upon completion of investigation.This report is number 3 of 3 mdrs filed for the same event (reference 3005739886-2023-00016).
Additional Manufacturer Narrative
H3 device evaluation - only the proximal portion of the screws were returned as the distal fracture segments remain in the patient.The complaint notes compression of the construct and broken screws with breakages noted at both sacral screws and the right l5 screw.Immediate post op images from the original procedure as well as the preop images prior to the revision were not provided so assessment of the change in construct condition was not assessed.Complete fusion was not evident as reported.The fracture planes on the broken screws were reviewed by eye and with the aid of a 5x loop.It is believed that the screws fractured via low cycle fatigue.The lock screws' rod contact surfaces were examined by eye and with the aid of a 5x loop.Only normal wear due to locking was observed as excessive wear due to looseness was not present.Based upon the reported loss of construct compression, broken screws, no signs of construct lock screw looseness, and full fusion not evident at any level it is believed that the screws broke under preload conditions that may have been applied in an effort to decompress the nerves on the left side prior to attaining fusion over that 10-month period.Review of device history records found (b)(4) pieces of this lot released for distribution on 7/12/2021 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for this product family of screws.No corrective actions are recommended at this time.This report is number 3 of 3 mdrs filed for the same event (reference (b)(4)).
Event or Problem Description
It was reported that an l4/l5/s1 procedure was performed on (b)(6) 2023, utilizing the reform ti modular cannulated pedicle screw system.Subsequently, the patient presented with pain and radiographical analysis showed compression of the construct and three (3) broken ø6.5mm x 55mm reform ti modular cannulated screws (39-sk-6555).A revision procedure was performed on (b)(6) 2024, during which all hardware was removed and replaced, with the exception of one side of l5 where tip portion of the broken screw remains.

• Brand Name: REFORM TI MODULAR
• Common Device Name: MODULAR BONE SCREW, CANNULATED
• 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: 18935456
• Report Number: 3005739886-2024-00018
• Device Sequence Number: 17899121
• Product Code: MNI
• UDI-Device Identifier: 00840019933643
• UDI-Public: 00840019933643
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 02/21/2024
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 39-SK-6555
• Device Lot Number: 36711PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• 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