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

Catalog Number	2968040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Event or Problem Description
It was reported that patient with lumbar kyphosis underwent oblique lumbar interbody fusion at l4/5.Intra-op, cage broke.The cage was inserted halfway, then it was removed because its position was not proper.When the surgeon checked the cage, it was found that its connecting part with the inserter was damaged.No fragments of the product remained inside the patient.No patient complications were reported.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: product analysis :optical and microscopic examination of the implant identified two of the inserter interface flanges, both on the same side, have been broken off, consistent with bend stress loading during attempted insertion.Additionally, the threaded hole has been stripped and there is deformation on the top face of the implant, consistent with significant impact.The fracture of the implant flanges are consistent with bend stress overload.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLYDESDALE 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: 6321568
• Report Number: 1030489-2017-00269
• Device Sequence Number: 16450550
• Product Code: MAX
• UDI-Device Identifier: 00613994485878
• UDI-Public: 00613994485878
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000058
• 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,Followup
• Report Date (Section B): 04/20/2017

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: 02/12/2024
• Device Catalogue Number: 2968040
• Device Lot Number: H5244500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Initial Date Received by Manufacturer: 01/16/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 04/20/2017
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 03/01/2017; 04/21/2017; 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR