MAUDE Adverse Event Report: PRECISION SPINE, INC. REFORM MC SCREW SYSTEM; SCREWDRIVER

Model Number	59-SP-0601
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other serious (important medical events) - this is being reported as a serious injury (retained foreign object) due to the fractured tip of the driver being left in the head of the polyaxial screw implanted in the patient.It is important to note that once the rod implant is seated and locked into the tulip of the polyaxial screw, the fractured tip is prevented from dislodging as long as the rod remains firmly locked in place.Initial reporter occupation - other; sales representative.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) 2023, utilizing the reform mc pedicle screw system.While attempting to adjust a screw, the tip of the adjustable driver (59-sp-0601) broke.The broken tip piece was left in the head of the screw implanted in the patient.The procedure was completed utilizing other instrumentation, readily available in the set.There was no delay to the procedure.
Additional Manufacturer Narrative
H3 device evaluation - the tip of the driver is fractured.The fracture plane is perpendicular to the driver's longitudinal axis.This failure mode is indicative of a torsional overload failure but crack initiation from a prior high loading condition can not be ruled out as being a contributing factor to this failure.Review of device history records found (b)(4) pieces of lot 00792up released for distribution on 6/16/2020 with no deviation or anomalies.Two-year complaint history review did not identify a trend for reports of this nature for this part number.No corrective actions are recommended at this time.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2023, utilizing the reform mc pedicle screw system.While attempting to adjust a screw, the tip of the adjustable driver (59-sp-0601) broke.The broken tip piece was left in the head of the screw implanted in the patient.The procedure was completed utilizing other instrumentation, readily available in the set.There was no delay to the procedure.

• Brand Name: REFORM MC SCREW SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; 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: 16336882
• Report Number: 3005739886-2023-00005
• Device Sequence Number: 6431353
• Product Code: HXX
• UDI-Device Identifier: 00840019927987
• UDI-Public: 00840019927987
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2023

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: 59-SP-0601
• Device Catalogue Number: 59-SP-0601
• Device Lot Number: 00792UP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/16/2023
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown