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

Catalog Number	2991226
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent surgery due to spinal degeneration.Intra-op, there was a crack in the cage.The device came in contact with the patient.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
The spacer does not appear to be broken.There is some damage to the scalloped area of the spacer.The flow of the material is consistent with the spacer being implanted.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7698643
• Report Number: 1030489-2018-01023
• Device Sequence Number: 848602
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 03/07/2025
• Device Catalogue Number: 2991226
• Device Lot Number: H5341201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 08/23/2018; 08/08/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 09/20/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1