MAUDE Adverse Event Report: SYNTHES GMBH VBS W/BALLOON SM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 09.804.600S

Device Problem Material Integrity Problem (2978)

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

Event Date 06/16/2022

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in japan as follows: it was reported that this was a percutaneous vertebroplasty (l1) procedure to treat centrum fracture due to osteoporosis on (b)(6) 2022.During the procedure three breakage events took place as follows: the trial balloon on the left was inflated up to 16 atm with 4.0 ml of saline solution.While the trial balloon was staying under such a condition, atm suddenly dropped to 0.It was found that the trial balloon had broken.Both the saline solution and contrast medium were suctioned from the lesion.Next, the stent balloon on the left was also inflated up to 16 atm with 4.0 ml of saline solution.While the stent was keeping its shape fine, atm suddenly dropped to 0, and they confirmed another balloon¿s breakage.Finally, a posterior area on the stent balloon on the right was not inflated.While the surgeon and the sales rep were discussing how to cope with the event, atm suddenly dropped to 0.The 3rd breakage was confirmed.Cement application was completed on both sides.All three broken devices were checked postoperatively and found that breakage status and breakage locations are same in all three devices.The patient had much inferior bone density.No further information is available.This report is for one (1) vbs w/balloon sm.This is report 1 of 3 for complaint (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.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa.Device evaluated by mfr: 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: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 15027590
• MDR Text Key: 304722864
• Report Number: 8030965-2022-04866
• Device Sequence Number: 1
• Product Code: KWQ
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09.804.600S
• Device Lot Number: 82236541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2022
• 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
• Treatment: VBS W/BALLOON SM; VBS W/BALLOON SM