MAUDE Adverse Event Report: SYNTHES GMBH UNK - VERTEBRAL BODY REPLACEMENT - EXPANDABLE: XRL; ORTHOSIS,SPONDYLOLISTHESIS SPINAL FIXATION

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

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown vertebral body replacement - expandable: xrl/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j 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.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) for patients undergoing spinal surgery failed spinal surgery has been identified as the reported complication as per spine tango registry report experienced by the following with corresponding intervention: surgical operations - postop surgical before discharge: 1 patient had an epidural hematoma.Reoperations: 1 patient had a reoperation because of hardware removal.1 patient had a reoperation because of instability.1 patient had a reoperation because of other reasons.This is for depuy synthes spine xlr implants.A copy of the clinical evaluation form is being submitted with this regulatory report.This report is for one (1) unk - vertebral body replacement - expandable: xrl.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - VERTEBRAL BODY REPLACEMENT - EXPANDABLE: XRL
• Type of Device: ORTHOSIS,SPONDYLOLISTHESIS SPINAL FIXATION
• 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: 11193581
• MDR Text Key: 230519515
• Report Number: 8030965-2021-00377
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• 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: 12/29/2020
• 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
• Patient Outcome(s): Required Intervention