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

Catalog Number	3992206
Medical Device Problem Codes	Break (1069); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Pre-operative diagnosis for this procedure : lcs type of procedure or technique used: transforaminal lumbar interbody fusion (tlif) levels: l5/s1 it was reported that intra-op, the intervertebral disc space was managed to be widened for inserting the cage.The cage was inserted in a wrong direction.It was hard to insert the cage and the cage was broken in the process of being hit.After that, the direction was confirmed by the perspective image.It was said that there was no problem because the cage was inserted without problems after the image confirmation.The product came in contact with the patient.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: the spacer was returned having fractured at the bottom of the two inserter locating tabs.The fracture emanates from the bottom of the locating tabs and traveled to the outer edge of the spacer.This type of fracture is consistent with compression overload during implantation, that can be the result of the spacer not having a lager enough open area to be installed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSTONE 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: 7554987
• Report Number: 1030489-2018-00778
• Device Sequence Number: 176940
• Product Code: MAX
• UDI-Device Identifier: 00643169187573
• UDI-Public: 00643169187573
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2018

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: 07/26/2025
• Device Catalogue Number: 3992206
• Device Lot Number: H5356040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1