MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM MIDLINE CORTICAL SCREW SYSTEM; PEDICLE SCREW

Catalog Number	59-BP-6545
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	05/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 lot number - unknown h4 device manufacture date - unknown without lot identification h3 device evaluation - the complaint device was ultimately implanted and cannot be returned for evaluation.Without the opportunity to examine the complaint product no conclusions can be drawn regarding the root cause of the reported malfunction.Review of device history records and lot specific complaint history review were not possible without lot identification.Two-year complaint history review did not reveal a trend for reports of this nature for this part number.This report is number 2 of 2 mdrs filed for the same event (reference (b)(4).
Event or Problem Description
It was reported that a procedure was performed in australia on (b)(6) 2024, utilizing the reform mc midline cortical screw system.While inserting a reform ti modular polyaxial tulip assembly (39-mt-0401) assembled on a ø6.5 x 45mm midline cortical bone screw (59-bp-6545) the tulip came off of the screw when the driver was removed.The tulip dropped into the wound and was retrieved using forceps.The tulip was then snapped back onto the screw shank and the procedure was completed with only a short delay.

• Brand Name: REFORM MIDLINE CORTICAL SCREW SYSTEM
• Common Device Name: PEDICLE 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: 19608477
• Report Number: 3005739886-2024-00030
• Device Sequence Number: 20884107
• Product Code: NKB
• UDI-Device Identifier: 00815362026342
• UDI-Public: 00815362026342
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/30/2024

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: 59-BP-6545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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