MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: USS; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problem Perforation of Vessels (2135)

Event Type  Injury  

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 with thoracolumbar fractures with stabilization using tslp system and uss.Following complications have been identified with corresponding intervention: tslp: 1 patient had intra-operative ae: vessel injury.1 patient had subsequent surgery prior to discharge due to infection of posterior access.1 patient had subsequent surgery prior to discharge due to unilateral rod dislocation.1 patient had subsequent surgery prior to discharge due to fistula of chylus.Tslp and uss: 1 patient had intra-operative ae: vessel injury 1 patient had subsequent surgery prior to discharge due to infection of posterior access.1 patient had subsequent surgery prior to discharge due to fistula of chylus.This is for depuy synthes uss system.It captures the reported intra-operative vessel injury.This is report 2 of 4 for (b)(4).

Manufacturer Narrative

510k: this report is for an unknown uss system/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.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.

• Brand Name: UNK - CONSTRUCTS: USS
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• 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: 13154243
• MDR Text Key: 283168352
• Report Number: 8030965-2022-00035
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention