MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Device Problem Migration or Expulsion of Device (1395)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.This report is for unk - vertebral body replacement - expandable: synex.Part and lot numbers are unknown.Without the specific part and lot number, the udi is not available.Complainant device is not expected to be returned for manufacturer review/investigation.(510k#): unknown.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.(b)(4).

Event Description

This report is being filed after the subsequent review of the following literature article: krbec (2002) replacement of the vertebral body by an expansion implant (synex).Acta chirurgiae orthopaedicae et traumatologiae czechosl, volume 69, pages 158-162.Czech republic.The aim of this study was to describe replacement of the vertebral body with the expansion implant synex.About 14 patients had vertebral fractures, 6 patients had post-traumatic kyphosis, 8 patients had vertebral metastatic tumors and 6 patients had a primary tumor.This is a retrospective review of a study conducted between january 2000 until june 2001, where the above 34 patients underwent treatment for replacement of the vertebral body with synex implants.In 25 cases, the body replacement was aided by a posterior fixation with an internal fixator; in 9 cases, an anterior stabilization with a ventrofix-type fixator was used.The post-surgery time period is in the range of 2-24 months, with an average of 13 months.The implant never failed in the sense of migrating or changing the position of the implant.There was no migration of the implant.Complications in terms of loosening of the additional posterior or anterior internal fixator were not recorded.However, the following complications listed below were noted: one patient was sick and died 7 months after surgery due to multiple organ metastases.One patient experienced a local recurrence of the tumor causing paraparesis, for which it was necessary to re-decompress the spinal canal.Two patients with post-traumatic kyphosis treated solely from the anterior approach (synex + ventrofix) experienced loss of correction in terms of kyphotization of up to 10 degrees.One patient experienced post-surgical displacement of the implant component by 1 tooth without affecting the course of treatment.This report is for an unknown vertebral body replacement synex.This report is for one (1) patient experienced post-surgical displacement of the implant component by 1 tooth without affecting the course of treatment.This is report 2 of 2 for (b)(4).

• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7267172
• MDR Text Key: 100150799
• Report Number: 8030965-2018-51074
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: EZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/30/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1