MAUDE Adverse Event Report: SYNTHES GMBH UNK - CAGE/SPACERS/BIO; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown cervios chronos peek c cage/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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: gulbis, a.Et al (2019), retrospective data analysis of anterior cervical discectomies and fusion without plate and screws, proceedings of the latvian academy of sciences.Section b, vol.73 (5), pages 433¿439 (latvia).The aim of this retrospective study was to collect and analyse data from microscope-assisted anterior cervical discectomy and fusion surgeries without plate and screws during a four-year period of time.Between 2013 to 2017, a total of 198 patients (81 male and 117 female) with a mean age of 48±1 years were surgically treated.All patients underwent an elective microscope-assisted anterior cervical discectomy and fusion (acdf) without inserting plate and screws.Four types of cages were used in similar number of operation: cervios peek chronos c (n=47), syncage c (n=41), eit 3d print (n=58), cervios c peek (n=52).The mean follow-up period was unknown.The following complications were reported as follows: 10 patients with syncage c had subsidence of cage at c 6/7 level.9 patients with cervios chronos peek c and cervios c peek cage had pseudoarthrosis.This report is for an unknown synthes cervios chronos peek c cage, and unknown synthes cervios c peek cage.It captures the reported event of pseudoarthrosis (n=9).This is report 2 of 2 for (b)(4).

• Brand Name: UNK - CAGE/SPACERS/BIO
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12895568
• MDR Text Key: 281433910
• Report Number: 8030965-2021-09819
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: LG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• 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
• Patient Outcome(s): Required Intervention