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

Model Number	10 MM X 9 MM
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record of the batch (160100) was reviewed and no deviation was detected.The medical device complied with the specification.The cage was expanded to the maximum (maybe up to or more than 10 turns) and the stresses applied to the cage probably caused the screw breakage.The surgical technique states that two cages must be implanted in the intervertebral space.In this case, just one cage, implanted using an oblique approach was implanted.We are waiting for the x-rays to confirm the screw breakage of the cage and to determine the root cause.Submission of a medical device report and the fda's release of that information is not an admission that a product, user facility, importer, distributor, manufacturer, or medical personnel caused or contributed to the event.
Event or Problem Description
During surgery the surgeon expanded (maybe up to more than 10 turns) l-varlock lumbar cage.The surgeon reported that he felt the expansion screw broke since the screwdriver kept spinning.To date we do not have visual confirmation that the screw broke after several requests to the surgeon.Submission of a medical device report and the fda's release of that information is not an admission that a product, user facility, importer, distributor, manufacturer, or medical personnel caused or contributed to the event.

• 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: 7453331
• Report Number: 3005440746-2018-00003
• Device Sequence Number: 19072420
• Product Code: MAX
• UDI-Device Identifier: 03700406328018
• UDI-Public: (01)03700406328018
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K080537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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: 10 MM X 9 MM
• Device Catalogue Number: VAL-CA 10-09
• Device Lot Number: 160100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2018
• 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: 60 YR