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

Catalog Number	2991226
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although it is unknown whether the product caused or contributed to the reported event, we are filling this mdr for notification purpose.Neither the device nor films of applicable imaging studies were 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 patient underwent transforaminal lumbar inter-body fusion surgery (tlif) due to disc herniation.Intra-operatively, during the implantation, spacer broke.The doctor removed it and replaced with a new one and the operation was completed smoothly.Product came in contact with the patient.No fragment of the implant remained in the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis result: visual the spacer does not appear to be broken the only damage is to the back side of the spacer and appears to be the result of grabbing the spacer during removal.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSTONE 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: 7514164
• Report Number: 1030489-2018-00679
• Device Sequence Number: 1169749
• Product Code: MAX
• UDI-Device Identifier: 00613994290953
• UDI-Public: 00613994290953
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K073291
• 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): 09/21/2018

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: 12/14/2024
• Device Catalogue Number: 2991226
• Device Lot Number: H5327726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1