MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CLYDESDALE PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	4986855
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Image review:- review of submitted images appear to display implant fracture through the cross sectional area and at one of the inserter interface tabs, with deformation on the top face, and some indication of stripped threads.
Event or Problem Description
Procedure: oblique lumbar interbody fusion (olif) levels implanted: l3/4/5 it was reported that during surgery, the cage broke during insertion.When the breakage occurred, 4/5 of the cage had been inserted in the vertebral body.So only 1/5 of the broken cage could be removed.This 1/5 fragment of the cage remained inside the patient.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional info: product analysis: visual review of the returned implant identified a portion has been broken off.Microscopic examination of the inserter interface identified a stripped threaded hole and deformation on the top face, and fracture on one side around the inserter tang interface, consistent with significant impact and torsional loading.Microscopic examination of the fracture surface of the broken off portion of the implant identified a fairly flat fracture with rays emanating away from the area of crack initiation, consistent with brittle overload.The above observations are consistent with inappropriate handling of the implant during attempted implantation.After completed analysis, no evidence was found that would suggest a defect in design or manufacturing of the implant.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLYDESDALE PTC SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 6452722
• Report Number: 1030489-2017-00734
• Device Sequence Number: 18997164
• Product Code: MAX
• UDI-Device Identifier: 00643169190511
• UDI-Public: 00643169190511
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2017

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 Expiration Date: 09/30/2024
• Device Catalogue Number: 4986855
• Device Lot Number: H5279567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Initial Date Received by Manufacturer: 03/09/2017
• Supplement Date Received by Manufacturer: Not provided; 06/06/2017
• Initial Report FDA Received Date: 04/03/2017
• Supplement Report FDA Received Date: 06/28/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR