MAUDE Adverse Event Report: PRECISION SPINE, INC. SURELOK MIS 3L; ROD INSERTER

Model Number	63-SP-9005
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information - unknown.Occupation - other; distributor.Device evaluation - information provided indicates that the product is available for evaluation but to date has not been received.Upon receipt and completion of investigation, a follow-up medwatch report will be submitted.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2021-00001).
Event or Problem Description
A 3-level mis posterior fixation plus fusion procedure was performed on (b)(6) 2020 in (b)(6), utilizing the sure-lok mis 3l system.When the surgeon was "punching" on the cage to locate it in its position, the tlif cage peek 8mm x 30mm (tlif30-08p) broke inside the patient.The surgeon was able to remove the broken cage and another was inserted successfully.After placing cages and beginning to fix the screws, while placing the second rod, the surgeon was inserting the lock-screw, a strange sound was heard, and it was found that the tip of the cl rod inserter (63-cl-9005) was broken off.The broken piece was removed and the procedure was completed successfully as the rod was already in place.There was no patient harm reported, but there was a one (1) hour delay to the procedure as a result of these malfunctions.
Additional Manufacturer Narrative
The inserter was returned for evaluation with the distal fractured tip.The laser markings are crisp and legible, and the gold knob freely turns, driving the center shaft in and out.The distal tip was returned plastically deformed.An evident twist suggests the inserter was subjected to a large anti-clockwise load from the perspective of looking down the shaft of the inserter from the handle.The condition of the fracture location is in agreement with the results concluded in testing reports in which the inserter is overloaded to 160 in-lbs.Review of device history records found that a total of (b)(4) pieces released for distribution between 4/16/2018 & 4/20/2018 with no deviation or anomalies.Two-year complaint history review found this to be the only report of this nature for this lot.No corrective action is recommended at this time due to the likelihood the failure can be attributed to an excessive load (torque) applied to the instrument.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2021-00001-1 / 00002-1).
Event or Problem Description
A 3-level mis posterior fixation plus fusion procedure was performed on (b)(6) 2020 in (b)(6) uae, utilizing the sure-lok mis 3l system.When the surgeon was "punching" on the cage to locate it in its position, the tlif cage peek 8mm x 30mm (tlif30-08p) broke inside the patient.The surgeon was able to remove the broken cage and another was inserted successfully.After placing cages and beginning to fix the screws, while placing the second rod, the surgeon was inserting the lock-screw, a strange sound was heard, and it was found that the tip of the cl rod inserter (63-cl-9005) was broken off.The broken piece was removed and the procedure was completed successfully as the rod was already in place.There was no patient harm reported, but there was a one (1) hour delay to the procedure as a result of these malfunctions.

• Brand Name: SURELOK MIS 3L
• Common Device Name: ROD INSERTER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 11108460
• Report Number: 3005739886-2021-00002
• Device Sequence Number: 3950121
• Product Code: LXH
• UDI-Device Identifier: 00840019920179
• UDI-Public: 00840019920179
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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-SP-9005
• Device Catalogue Number: 63-SP-9005
• Device Lot Number: 17020AP-R05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention