MAUDE Adverse Event Report: SYNTHES GMBH VERTECEM V+ CEMENT KIT; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 07.702.016S

Device Problem Improper Chemical Reaction (2952)

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

Event Date 12/07/2023

Event Type  malfunction  

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: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: 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.

Event Description

Device report from synthes reports an event in japan as follows: it was reported during a percutaneous vertebroplasty (l1) for osteoporotic vertebral fracture on (b)(6) 2023 there was an issue with the cement.In the surgery, the surgeon performed the cement mixing according to the procedure manual.The cement did not reach optimum viscosity at all after more than 30 minutes.The cement is a product used by filling a syringe with cement, but the syringe that had been checked for viscosity did not increase its viscosity at all even after 30 minutes or more had passed.When the surgeon checked other syringes during the process, some of them were already hardened and could not be used, so there was a big difference in viscosity among syringes.The cement was filled into the body because the usable time was well past.The cement was nicely filled in the vertebral body, but some of the cement became cobwebbed and spread around the posterior wall of the vertebral body, which is seen when the viscosity does not reach the optimum viscosity.The posterior wall of the vertebral body was very close to the spinal canal and there was a risk of cement flowing into the lungs and other organs from there.It was suspected that the cement viscosity was not equalized in the syringe.The surgery was completed successfully within 30 minutes surgical delay.Patient was stable.This report is for vertecem v+ cement kit 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.H4, h6 product code: : 07.702.016s, lot number : 3b53590, release to warehouse date : 03.Feb.2023, expiration date : 01.Feb.2026, supplier: (b)(4), manufacturing site: werk selzach.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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: VERTECEM V+ CEMENT KIT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18419334
• MDR Text Key: 331718449
• Report Number: 8030965-2023-16354
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819376250
• UDI-Public: (01)07611819376250
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.702.016S
• Device Lot Number: 3B53590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1