MAUDE Adverse Event Report: VBS W/BALLOON MED; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Catalog Number 09.804.601S

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

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

Device report from synthes reports an event in (b)(6) as follows: it was reported that this was a percutaneous vertebroplasty (th11) for treating centrum fracture on (b)(6), 2021.The stent balloon was not inflated evenly, leaving one end less inflated.As further inflation might result in a more deformed stent shape, the surgeon stopped inflation and moved on to cement application.Next, the surgeon experienced difficulty in connecting a needle to the balloon due to the balloon's deformed shape.The surgeon ultimately applied cement with the help of an access kit.The procedure was completed less than 30-minute surgical delay.No further information is available.This report is for one (1) vbs w/balloon med.This is report 1 of 1 for (b)(4).

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.H10 additional narrative: h6 - codes updated to imdrf codes.The photo was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device from attachment(photos_(b)(4)_(b)(6) hospital(sp202100282) visual analysis of the x ray revealed that vbs w/balloon med has been inflated.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for vbs w/balloon med.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot - dhr cannot be performed since lot number is unk.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: VBS W/BALLOON MED
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• MDR Report Key: 12656293
• MDR Text Key: 277423276
• Report Number: 8030965-2021-08769
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 07611819471856
• UDI-Public: (01)07611819471856
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09.804.601S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - BIOMATERIAL - CEMENT.