MAUDE Adverse Event Report: PRECISION SPINE, INC SURELOK MIS 3L; PEDICLE SCREW

Model Number	63-CP-6545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 device evaluation - complaint product was not returned.No conclusions can be drawn.Review of device history records found 112 pieces of lot 36145ps released for distribution on 6/4/2021 with no deviation or anomalies.(b)(4).
Event or Problem Description
It was reported that a revision procedure was performed to address a sure-lok mis triple lead screw 6.5mm x 45 mm (63-cp-6545) that failed post operatively.The screw broke just under the head.No additional details are available at this time.

• Brand Name: SURELOK MIS 3L
• 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: 17098979
• Report Number: 3005739886-2023-00025
• Device Sequence Number: 7812783
• Product Code: MNI
• UDI-Device Identifier: 00840019905510
• UDI-Public: 00840019905510
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2023

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: 63-CP-6545
• Device Catalogue Number: 63-CP-6545
• Device Lot Number: 36145PS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• 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