MAUDE Adverse Event Report: SYNTHES GMBH UNK - VERTEBRAL BODY REPLACEMENT - EXPANDABLE: SYNEX; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.510k: this report is for an unknown synex expandable vertebral body replacement/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between 2004 and (b)(6) 2021.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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.(b)(4).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 a clinical evaluation report (cer) from a related research activity database (ddra) to compare usage and outcomes recorded in 11 patients (5 males and 6 females) for synex implants against all other surgical cases recorded within the spine tango registry between 2004 and april 19, 2021.Final registry report outcome description: general complications- intraoperative 7 unknown.General complications- postoperative surgical before discharge 1 not documented.7 unknown.Surgical complications- intraoperative adverse events 1 dural lesion.7 unknown.Surgical complications- postoperative surgical before discharge 1 not documented.7 unknown.Reoperations: 1 reoperations at any level.1 reoperations at the same level.This is for depuy synthes synex implants.This report is for one (1) unknown synex expandable vertebral body replacement.This is report 4 of 5 for (b)(4).

Event Description

Updated event description: this report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) to compare usage and outcomes recorded in 32 patients (33 procedures) for synex implants against all other surgical cases recorded within the spine tango registry between 2006 - 2024.Final registry report outcome description: general complications: intraoperative: 25 not documented.General complications: postoperative surgical before discharge: 29 not documented.Surgical complications: intraoperative adverse events: 1 dural lesion; 7 not documented.Surgical complications: postoperative surgical before discharge: 29 not documented.Reoperations: 4 reoperations at any level; 3 reoperations at the same level this is for depuy synthes synex implants.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

• Brand Name: UNK - VERTEBRAL BODY REPLACEMENT - EXPANDABLE: SYNEX
• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11809324
• MDR Text Key: 264702741
• Report Number: 8030965-2021-03810
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• 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: 01/17/2024
• 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