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	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information - unknown occupation - other; distributor evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2021-00016 / 00017).
Event or Problem Description
It was reported from (b)(6) that the cl rod inserter (63-sp-9005) is not holding the rod in the inserter properly.The gold knob is not functioning as intended.It was not indicated that this caused any issues during a procedure.
Event or Problem Description
It was reported from saudi arabia that the cl rod inserter (63-sp-9005) is not holding the rod in the inserter properly.The gold knob is not functioning as intended.It was not indicated that this caused any issues during a procedure.
Additional Manufacturer Narrative
H3 device evaluation - complaint product was inadvertently misplaced following receipt.No evaluation is possible, and no conclusions can be drawn.Should the product be located, a follow-up medwatch report will be submitted when evaluation is complete.This report is number 2 of 2 mdrs filed for the same event (reference 3005739886-2021-00016-1).

• Brand Name: SURELOK MIS 3L
• Common Device Name: ROD INSERTER
• 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: 11440437
• Report Number: 3005739886-2021-00017
• Device Sequence Number: 5425208
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 63-SP-9005
• Device Catalogue Number: 63-SP-9005
• Device Lot Number: 1033AP-R05
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/25/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2020
• 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
• Patient Sex: Unknown