MAUDE Adverse Event Report: MSD DEGGENDORF MFG VERTE-STACK SPINAL SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	6278025
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Event or Problem Description
It was reported that patient with central stenosis underwent cervical corpectomy at c4-6.Intra-op, the cage(end cap) appeared to come apart from strut.Under x-ray, the cage appeared to be mis-aligned.When it was removed, the end caps fell out of strut and appeared that the strut could not hold the end caps securely like normal.There were no fragments remaining in the patient.There were no patient complications as a result of this event.It would appear the strut maybe the issue and wouldn't fully lock in with with the end caps.
Additional Manufacturer Narrative
Additional information: product analysis : visual review did not identify crack, fracture, or material deformation to any of the returned implants.Functional evaluation with the returned implants found the strut able to fully engage each spacer, with an audible "click" heard, and tactile confirmation the spacers were fully engaged.Grasping the strut and manually shaking the assembly was unable to disengage either of the spacers.The implants appear to be capable of performing their intended function.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERTE-STACK SPINAL SYSTEM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• MDR Report Key: 6566164
• Report Number: 1030489-2017-01223
• Device Sequence Number: 1049536
• Product Code: MQP
• UDI-Device Identifier: 00721902913204
• UDI-Public: 00721902913204
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K030736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2017

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: 10/09/2020
• Device Catalogue Number: 6278025
• Device Lot Number: WL59
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 05/15/2017
• Supplement Report FDA Received Date: 08/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPACER ENDCAPS