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

Catalog Number	2990926
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the re ported 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 lumbar interbody fusion at l3/4/5 due to degenerative scoliosis.Intra-op, the cage was inserted from the left of l4/5, while being hammered, physician confirmed from the perspective image that the marker looked different from usual.When the physician attempted to adjust the marker to be reflected on the true sagittal, cage broke along with a snap sound.A new cage of one size smaller was opened to deal with issue.No fragment remains in the patient.No patient symptoms or complication were reported as result of this event.
Additional Manufacturer Narrative
Product analysis result: visual microscopic visual and microscopic examination identified a portion of the top face and corner of the implant, which interfaces directly with the inserter has been broken off.Two small pieces were returned for analysis and the other part of the broken portion was not returned.Optical and microscopic examination of the implant identified a brittle fracture with rays emanating from the root of the thread tooth.The above observations are consistent with significant force applied to the implant during attempted implantation.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: 8104996
• Report Number: 1030489-2018-01558
• Device Sequence Number: 1900822
• Product Code: MAX
• UDI-Device Identifier: 00613994387370
• UDI-Public: 00613994387370
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/04/2019

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: 01/24/2021
• Device Catalogue Number: 2990926
• Device Lot Number: H12V2360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2019
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR