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 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.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 (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2021, it was noticed that the cement could not be mixed.During mixing, it changed color to grey and hardened immediately and could not be put into the syringe.Five (5) packets of cement were used.The same issue was experienced with each packet.Surgery completed successfully with another available product.There was a delay of thirty minutes.Patient outcome was well.This report is for a vertecem v+ cement kit.This is report 3 of 5 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.H6: a device history record (dhr) review was conducted: part: 07.702.016s, lot: 1b53380, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 02 february 2021, expiration date: 01 february 2024.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
• MDR Report Key: 12350375
• MDR Text Key: 267556647
• Report Number: 8030965-2021-07014
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819376250
• UDI-Public: (01)07611819376250
• 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: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Catalogue Number: 07.702.016S
• Device Lot Number: 1B53380
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/20/2021
• Supplement Dates Manufacturer Received: 08/24/2021
• Supplement Dates FDA Received: 09/20/2021
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SISTEMA DE CEMENTO VERTECEM V+ . ESTERIL; SISTEMA DE CEMENTO VERTECEM V+ . ESTERIL; SISTEMA DE CEMENTO VERTECEM V+ . ESTERIL; SISTEMA DE CEMENTO VERTECEM V+ . ESTERIL; SISTEMA DE CEMENTO VERTECEM V+ . ESTERIL; SISTEMA DE CEMENTO VERTECEM V+ . ESTERIL; SISTEMA DE CEMENTO VERTECEM V+ . ESTERIL; SISTEMA DE CEMENTO VERTECEM V+ . ESTERIL