MAUDE Adverse Event Report: PRECISION SPINE, INC SHURFIT LUMBAR INTERBODY; INSERTER

Model Number	72-IN1001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other - evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2024, utilizing the shurfit 3d titanium interbody cage system.The surgeon was using a mallet to place the cage into the proper position when the tip of two different assembly, inserter, posterior curved cage (72-in-1001) broke.The broken pieces with a pickup and the procedure was successfully completed by opening another set that was readily available.There was no patient injury or surgical delay.It was noted that the surgeon indicated the patient had very hard bone and does not allege the device had anything to do with the instrument failure.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2024, utilizing the shurfit 3d titanium interbody cage system.The surgeon was using a mallet to place the cage into the proper position when the tip of two different assembly, inserter, posterior curved cage (72-in-1001) broke.The broken pieces with a pickup and the procedure was successfully completed by opening another set that was readily available.There was no patient injury or surgical delay.It was noted that the surgeon indicated the patient had very hard bone and does not allege the device had anytihng to do with the instrument failure.
Additional Manufacturer Narrative
H3 device evaluation - both units of 72-in-1001 per lot code 27239sf were made to rev b design level.The issue associated with the fractured implant locking fork was previously addressed by a design change which was released 7/11/2023 with a use as is disposition for existing inventory.This change along with another improvement which released 1/26/24 with a use as is disposition for existing inventory further addresses the issue.These changes correspond to rev d and rev e.This failure has not occurred to units produced to the rev d and rev e design levels.Root cause analysis: insufficient material section of the implant locking fork to withstand impaction forces while positioning the implant.No additional corrective actions are required.

• Brand Name: SHURFIT LUMBAR INTERBODY
• Common Device Name: 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: 21139084
• Report Number: 3005739886-2025-00001
• Device Sequence Number: 20534748
• Product Code: LXH
• UDI-Device Identifier: 00840019960403
• UDI-Public: (01)00840019960403(11)20220113(10)27239SF
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2024

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: 72-IN1001
• Device Catalogue Number: 72-IN-1001
• Device Lot Number: 27239-SF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2022
• 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