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

Catalog Number 6278025

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/19/2017

Event Type  malfunction  

Manufacturer Narrative

The device is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.

Event 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.

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
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• Manufacturer (Section G): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6566164
• MDR Text Key: 75091465
• Report Number: 1030489-2017-01223
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00721902913204
• UDI-Public: 00721902913204
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/15/2017
• Supplement Dates Manufacturer Received: 07/31/2017
• Supplement Dates FDA Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SPACER ENDCAPS