MAUDE Adverse Event Report: SYNTHES GMBH UNK - CAGE/SPACERS; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown cage/spacer/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective, and/or preventative action is proposed.This complaint will be accounted for, and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: 'hur, j.W.Et al.(2020), comparative analysis of 2 different types of titanium mesh cage for single-level anterior cervical corpectomy and fusion in terms of postoperative subsidence and sagittal alignment, clinical spine surgery', vol.33(1), pages 1-5 (south korea).The objective of this study was to compare the differences in clinical and radiologic outcomes among patients who underwent anterior cervical corpectomy and fusion (accf) using titanium mesh cage (tmc) with end-caps and patients who underwent accf using tmc without end-caps.From september 2008 to june 2014, a total of 84 patients were included in the study.The study group consisted 38 patients (17 males and 21 females) with a mean age of 65.7 years who underwent tmc with end-caps.Implants used was a synmesh vertebral body replacement system (depuy synthes, raynham, ma).The control group used a pyramesh (medtronic sofamor danek, memphis, tn).Patients were followed postoperatively for a minimum of 36 months with radiologic evaluation.The following complications were reported as follows: cage subsidence occurred less an the end-cap group than the control group.Furthermore, the rate of severe subsidence, which was defined as subsidence >3 mm, was less frequent in the end-cap group than the control group.Posterior subsidence was more prominent than anterior subsidence in both groups.Cage inclination was significantly higher in the study group compared with the control group demonstrating slippage type subsidence in the end-cap group, and impaction type subsidence in control group.This report is for an unknown synthes synmesh.A copy of the literature article is being submitted with this medwatch.This report is for one (1) unk.Cage/spacers.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CAGE/SPACERS
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11032296
• MDR Text Key: 223057640
• Report Number: 8030965-2020-09828
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1