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

Catalog Number	4986045
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2018
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
It was reported that the patient was pre-operatively diagnosed with scoliosis and underwent oblique lumbar interbody fusion(olif) surgery at l2-5 levels.During surgery,the cage broke.The product came in contact with the patient.Fragments of the cage remains in the patient.About 90% of the cage was explanted.10% of it was not collected.There was a delay of less than 60 minutes in the overall procedure time as a result of this event.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: only one small portion of the implant returned for analysis (~3mm).Microscopic fracture surface examination identified rays emanating from the one corner of the implant surface.The above observations are consistent with brittle overload.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: 7796464
• Report Number: 1030489-2018-01155
• Device Sequence Number: 10819925
• Product Code: MAX
• UDI-Device Identifier: 00643169190733
• UDI-Public: 00643169190733
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

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: 03/21/2025
• Device Catalogue Number: 4986045
• Device Lot Number: H5335635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1