MAUDE Adverse Event Report: PRECISION SPINE, INC. SHURFIT INTERBODY DEVICE; INTERBODY FUSION CAGE

Model Number	TLIF30-08P
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: other; sales representative.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 the patient underwent a 2 level reform ti and shurfit tlif case (l2 - l4) performed on (b)(6) 2020.Per the surgeons technique, he placed the reform ti screws in first, distracted the l2-3 disc space with a lamina spreader, cleared the disc with general surgical instruments (kerrisons, pituitaries, shavers), and then inserted the 6mm shurfit tlif trial and then the 8mm shurfit tlif trial without any issues.Based on the 8mm trial sizing, he then inserted the tlif30-08p with the shurfit inserter.Upon malleting the back end of the inserter to place the cage into the disc space, the tlif cage broke in-situ.The broken piece was not in the disc space and was able to be removed and the procedure completed utilizing a competitor's interbody implant without any further issues.There was a ten (10) minute delay to the procedure reported.
Additional Manufacturer Narrative
H3 device evaluation - engineer's evaluation of the returned cage pieces was not able to determine a failure mode.As a failure mode cannot be determined, the need for corrective action was not indicated.Without lot number identification, review of device history records was not possible.Two-year complaint history review (12.18.2018-12.18.2020) found this to be the only report of this nature for this part number during this time frame.
Event or Problem Description
It was reported that the patient underwent a 2 level reform ti and shurfit tlif case (l2 - l4) performed on (b)(6) 2020.Per the surgeons technique, he placed the reform ti screws in first, distracted the l2-3 disc space with a lamina spreader, cleared the disc with general surgical instruments (kerrisons, pituitaries, shavers), and then inserted the 6mm shurfit tlif trial and then the 8mm shurfit tlif trial without any issues.Based on the 8mm trial sizing, he then inserted the tlif30-08p with the shurfit inserter.Upon malleting the back end of the inserter to place the cage into the disc space, the tlif cage broke in-situ.The broken piece was not in the disc space and was able to be removed and the procedure completed utilizing a competitor's interbody implant without any further issues.There was a ten (10) minute delay to the procedure reported.

• Brand Name: SHURFIT INTERBODY DEVICE
• Common Device Name: INTERBODY FUSION CAGE
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 11155204
• Report Number: 3005739886-2021-00004
• Device Sequence Number: 2590820
• Product Code: KWQ
• UDI-Device Identifier: 00840019909907
• UDI-Public: 00840019909907
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K092193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

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: TLIF30-08P
• Device Catalogue Number: TLIF30-08P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 01/19/2021
• 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: Required Intervention