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

Catalog Number	6278244
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Devices of multiple part/lot numbers were implanted during the procedure including: part: 6278244 / lot: vu88 (x2) part: 6278025 / lot: unk (x1).The manufacturer could not determine the suspected products.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.
Event or Problem Description
It was reported that the patient presented with pre-op diagnosis as: cervical stenosis.For which patient underwent a cervical corpectomy at levels c4-c7.Intra-op, the 3 pieces were snapped together and then packed well with bone.Implant was implanted and x-ray was taken which revealed that end cap had separated slightly from the strut, it was removed and examined.It was cleaned off and re attached together but once in patient, the end cap was loose.Therefore it was decided to open up a new middle strut and 2 new endcaps which worked very well.Products came in contact with the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: functional assembly and evaluation of the returned implants was unable to replicate issue with respect to spacer/strut interfaces.The implants were unable to be separated by manual loading of the construct assembly.Dimensional inspection of the relevant interfacing dimensions did identify an out-of-tolerance condition.A search of the complaint database did not identify any additional complaint returns with this part/lot# combination.The above observations are consistent with manufacturing error.A good faith effort will be made to obtain the applicable information relevant to the report.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: 6208060
• Report Number: 1030489-2016-03595
• Device Sequence Number: 50174
• Product Code: MQP
• UDI-Device Identifier: 00721902807527
• UDI-Public: 00721902807527
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K041197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/21/2020
• Device Catalogue Number: 6278244
• Device Lot Number: VU88
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2016
• Supplement Report FDA Received Date: 03/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1