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

Catalog Number 09.804.600S

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 02/10/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that this was an unknown procedure for treating l1 centrum fracture on (b)(6) 2022.After two surgeons inflated a trial balloon on each side up to 2.0ml, they checked and confirmed by imaging that inflation status on those balloons had no issues.Next, they exchanged the trial balloons with stent balloons and inflated them by 1.0ml.When the balloon on the left was inflated up to 2.0ml, it was revealed that the balloon had deviated from the original position and had stayed outside the centrum.The balloon was removed from the lesion, and the rest of the procedure was completed.The surgeon commented that his surgical technique might have triggered the event.No further information is available.This complaint involves one(1) device vbs w/balloon sm.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Device is not distributed in the united states but is similar to device marketed in the usa.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: VBS W/BALLOON SM
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13720287
• MDR Text Key: 290530844
• Report Number: 8030965-2022-01490
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819471849
• UDI-Public: (01)07611819471849
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• 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: 02/10/2022
• 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