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

Catalog Number	2968045
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2018
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient was pre-operatively diagnosed with lumbar spondylolisthesis and underwent oblique lumbar interbody fusion(olif) surgery.It was reported that during surgery, the cage broke during implantation.The product came in contact with the patient.No fragment of the broken cage were remaining in the patient.No patient complications were reported.
Additional Manufacturer Narrative
Image review: photo shows that the cage has broke near the end that connects to the inserter.Product analysis: a piece ~3.5mmx13mm has broken off the cage in the area that sits against the inserter.A microscopic review of the fracture surface gives indications that the material was overloaded during a bending moment with torsion being applied through the inserter (see attached photo).The failure appears to be the result of material overload during installation.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: 7608923
• Report Number: 1030489-2018-00859
• Device Sequence Number: 176234
• Product Code: MAX
• UDI-Device Identifier: 00613994485861
• UDI-Public: 00613994485861
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P000058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

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: Health Professional
• Device Expiration Date: 08/11/2025
• Device Catalogue Number: 2968045
• Device Lot Number: H5377880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1