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

Catalog Number	63-SP-9005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cl rod inserter (63-sp-9005) broke during surgery.Follow-up attempts to obtain details have been unsuccessful.
Additional Manufacturer Narrative
H3 device evaluation - information provided indicates that the device is available for return but to date, the product has not been received by the manufacturer.As device evaluation is not possible at this time, no conclusions can be drawn as to the root cause of the reported failure.Review of device history records found that (b)(4) of lot 00116pt-r released for distribution on 5/30/2019 with no deviation or anomalies.The -05 was added to the lot number subsequent to quality inspection performed to check for an anomaly found on another lot.The 05 indicates that there was no anomaly found.Two-year device history review did not reveal a trend for reports of this nature for this part number.No corrective actions are recommended at this time.Should the product be received, a follow-up report will be filed following device evaluation.

• Brand Name: SURELOK MIS 3L
• Common Device Name: ROD INSERTER
• 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: 17819719
• Report Number: 3005739886-2023-00044
• Device Sequence Number: 19453029
• Product Code: LXH
• UDI-Device Identifier: 00840019920179
• UDI-Public: 00840019920179
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2023

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 Catalogue Number: 63-SP-9005
• Device Lot Number: 00116PT-R05
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2019
• 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