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

Model Number	63-SP-9005
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: other; distributor.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
Event or Problem Description
A two-level procedure was performed in (b)(6), on (b)(6) 2020 utilizing the surelok mis 3l pedical screw system.While attempting to insert the first rod, the tip of the cl rod inserter (63-sp-9005) broke.The broken tip was removed from the patient and the procedure was completed utilizing an inserter from another system.There was no reported delay to the procedure.
Additional Manufacturer Narrative
H3 device evaluation: the inserter was returned for evaluation without 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 condition of the fracture location is in agreement with the results concluded in the attached report 1116191-cn04-rev0 in which the inserter is overloaded to 160 in-lbs.Review of device history records found 26 pieces were released for distribution on 5/30/2019 with no deviation or anomalies.Two-year complaint history review did not identify a trend for reports of this nature.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.
Event or Problem Description
A two-level procedure was performed in saudi arabia, on (b)(6) 2020 utilizing the surelok mis 3l pedical screw system.While attempting to insert the first rod, the tip of the cl rod inserter (63-sp-9005) broke.The broken tip was removed from the patient and the procedure was completed utilizing an inserter from another system.There was no reported delay to the procedure.

• Brand Name: SURELOK MIS 3L
• Common Device Name: INSERTER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 10329515
• Report Number: 3005739886-2020-00020
• Device Sequence Number: 991712
• Product Code: LXH
• UDI-Device Identifier: 00840019920179
• UDI-Public: 00840019920179
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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): 07/02/2020

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: 00116PT-R05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 12/28/2020
• 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: Required Intervention