MAUDE Adverse Event Report: KISCO INTERNATIONAL L-VARLOCK; LUMBAR POSTERIOR CAGE

Model Number	Lumbar posterior cage W10 H9
Medical Device Problem Codes	Fracture (1260); Material Torqued (2980)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record of the batch (15624) was reviewed and no deviation was detected.The medical device complied with the specifications.The broken cage has been checked.No deviation was detected and no material defect was observed under a magnifying glass on the broken surface of the screw.The traces of friction on the ramp what allows the cage expansion indicated that the cage was probably expanded to the maximum and the stresses applied to the cage probably caused the screw breakage.It is recommended to check if the posterior fixation is loose before the cage expansion and to stop the expansion if the screwing effort become too high.
Event or Problem Description
The l-varlock expansion screw broke when the surgeon expanded the cage (at the beginning of the expansion).No problem on the other side.It took some time before the surgeon could remove the broken implant.The broken implant was replaced by another l-varlock cage without a problem.

• Brand Name: L-VARLOCK
• Common Device Name: LUMBAR POSTERIOR CAGE
• Manufacturer (Section D): KISCO INTERNATIONAL; parc technologique; 2, place berthe morisot; saint priest, 69800 ; FR 69800
• MDR Report Key: 7453333
• Report Number: 3005440746-2018-00002
• Device Sequence Number: 1097534
• Product Code: MAX
• UDI-Device Identifier: 03700406328018
• UDI-Public: (01)03700406328018
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K080537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2018

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: Physician
• Device Model Number: Lumbar posterior cage W10 H9
• Device Catalogue Number: VAL-CA 10-09
• Device Lot Number: 15624
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 04/23/2018
• 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: Other
• Patient Age: 65 YR