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

Catalog Number	39-SB-5545
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a procedure to address an l1 fracture on (b)(6) 2023.The surgeon put screws at t12 and at l2 and did a laminectomy at l1, utilizing the reform ti modular cannulated pedicle screw system.Subsequently, a revision procedure was performed on (b)(6) 2023, to address two broken ø5.5mm x 45mm reform ti modular non-cannulated screws (39-sb-5545).The top two screws in the construct were found to be broken and were removed with forceps, the bottom two screws were also removed with a driver and t-handle.No new hardware was implanted as the surgeon felt there was adequate fusion across the fracture.
Additional Manufacturer Narrative
H3 other - evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.This report is number 1 of 2 mdrs filed for the same event (b)(4).
Event or Problem Description
It was reported that the patient underwent a procedure to address an l1 fracture on (b)(6) 2023.The surgeon put screws at t12 and at l2 and did a laminectomy at l1, utilizing the reform ti modular cannulated pedicle screw system.Subsequently, a revision procedure was performed on (b)(6) 2023, to address two broken ø5.5mm x 45mm reform ti modular non-cannulated screws (b)(6).The top two screws in the construct were found to be broken and were removed with forceps, the bottom two screw were also removed with a driver and t-handle.No new hardware was implanted as the surgeon felt there was adequate fusion across the fracture.
Additional Manufacturer Narrative
H3 device evaluation - a procedure was performed with screws placed at t12 and l2 and a laminectomy performed at l1 to treat an l1 fracture.The broken screws removed from t12 were sent out for sem evaluation.The results of those assessments note the failure mode was via fatigue.Both fractures initiated in the minor diameter at remnant tooling edge discontinuities.Short segment thoracolumbar implant failures are not uncommon.One paper, "current status of short segment fixation in the thoracolumbar spine injuries" notes implant failure rates ranging from 9 to 54% with short segment instrumentation.The article also attributes the failures to lack of anterior column integrity and the robustness of the constructs.No corrective actions are being recommended.This report is number 1 of 2 mdrs filed for the same event (reference 3005739886-2023-00055-1 / 00056-1).

• 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: 17931184
• Report Number: 3005739886-2023-00055
• Device Sequence Number: 6368447
• Product Code: NKB
• UDI-Device Identifier: 00840019931878
• UDI-Public: 00840019931878
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

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 Catalogue Number: 39-SB-5545
• Device Lot Number: 31838PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2020
• 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 Sex: Unknown