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

Model Number 63-CP-6545

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 316887242
• Report Number: 3005739886-2023-00025
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 00840019905510
• UDI-Public: 00840019905510
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 63-CP-6545
• Device Catalogue Number: 63-CP-6545
• Device Lot Number: 36145PS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention