MAUDE Adverse Event Report: SYNTHES GMBH VBS W/BALLOON SM; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 09.804.600S

Device Problem Material Integrity Problem (2978)

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

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 on (b)(6) 2021, the patient underwent for a percutaneous vertebroplasty treating l1 compression fracture surgery.The trial balloons broke.The procedure was completed less than 30-minute surgical delay.There was no adverse patient effect.No further information is available.This complaint involves (2) devices.This report is for (1) vbs w/balloon sm.This report is 1 of 2 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: g4: device is not distributed in the united states, but is similar to device marketed in the usa.H6: product was not returned.Based on the information available, it has been determined that no corrective and 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.D2a, d2b; h5.

• Brand Name: VBS W/BALLOON SM
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12336250
• MDR Text Key: 267058923
• Report Number: 8030965-2021-06769
• Device Sequence Number: 1
• Product Code: NDN
• 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: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09.804.600S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2021
• Patient Sequence Number: 1
• Treatment: VBS W/BALLOON SM; VBS W/BALLOON SM