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

Catalog Number 4332212

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4) (revision surgery).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.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.

Event Description

It was reported that on: (b)(6) 2004: the patient presented with symptomatic grade i lumbosacral spondylolisthesis with bilateral inter-articularis defects.The patient underwent the following procedures: posterior lumbar interbody fusion at the fifth lumbar disk level; placement of bilateral cages at l5-s1 interspace; use of moreclized autograft for lumbar interbody fusion; use of bone matrix protein allograft for lumbar interbody fusion; use of bone matrix protein allograft for lumbar inter-body fusion; right and left partial hemilaminectomy/discectomy; placement of pedicle screw fixation at the right and left l5 and s1 pedicles; use of intra-operative c-arm fluoroscopy; placement of i-flow on-q post-operative pain ball for post-operative pain control.As per-op notes, ¿12mm * 22mm plastic peek cage was placed in the left l5 interspace.This cage was packed with bmp allograft material.Additionally, the spaces between the two cages were packed with morcelized autograft.¿ the patient tolerated the procedure well.On (b)(6) 2004: the patient was discharged.On (b)(6) 2004: the patient presented with complaints of cage migration with nerve compression.The patient underwent posterior lumbar revision surgery with explantation of cages, re-instrumentation with pedicle screw fixation with implantable bone simulator, posterior lateral fusion mass.The patient then underwent alif l5-s1 with bak cage, infuse.No patient complications were reported.The patient also had complaint of loss of fixation of previously fused lumbosacral spondylilosthesis in an extremely obese person and underwent the following procedures: posterolateral lumbar fusion bilaterally at the l4, l5 and s1 level; fusion of posterolateral lumbar segment, each segment; exploration of previously done lumbosacral fusion; placement of posterior segmental instrumentation in the l4, l5 and s1 pedicles bilaterally; removal of posterior segmentation; re-exploration and laminectomy of lumbar levels, l4, l5 and s1; posterior laminectomy, facectomy and foraminotomy with redo discectomy; posterior laminectomy, facectomy and foraminotomy at the next segment.Posterior laminectomy, facectomy and foraminotomy at the next lumbar level.

Manufacturer Narrative

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
• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5912184
• MDR Text Key: 53438863
• Report Number: 1030489-2016-02435
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2008
• Device Catalogue Number: 4332212
• Device Lot Number: IC03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/08/2016
• Initial Date FDA Received: 08/29/2016
• Supplement Dates Manufacturer Received: 08/08/2016
• Supplement Dates FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR