MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH VERTECEM V+ CEMENT KIT; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 07.702.016S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

Patient¿s weight is unknown.Due to the intra-operative events, the device was not successfully implanted.As such, implant/explant dates are not applicable.Complainant device is not expected to be returned for manufacturer review/investigation.Reporter phone number is not provided for reporting.The (510k): device is not distributed in the united states, but is similar to device marketed in the usa.(b)(4) used to capture additional medical/surgical intervention required: the complaint indicated that the cement setting seems exceptional harder.The syringe cannot deliver out the cement.The surgeon attempted to use two kits with no success.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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 europe reports an event in (b)(6) as follows: it was reported that a patient underwent a vertebroplasty procedure on apr 24, 2018 and vertecem v+ cement kit was used.During the procedure, the cement setting seems exceptional harder which the syringe cannot deliver out.Two (2) packs used with similar problem.The product cannot return as it is bloody and set inside the syringe.The surgeon had to wait for another new pack of cement to be delivered.Surgery prolonged for about one hour.Surgery was done successfully with the new cement kit sent to hospital about one hour after the cement in question found not functioning in mixing.After surgery patient woke up soon with normal condition.This report is for one (1) vertecem v+ cement kit.This is report 2 of 2 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.A device history record review was performed for the subject device: part number: 07.702.016s.Synthes lot number: 7d53203.Manufacturing location: selzach.Supplier: external supplier aap biomaterials gmbh.Release to warehouse date: 21.Aug.2017.Expiry date: 01.Apr.2020.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The complained articles were not received for investigation the complaint therefore cannot be confirmed.The received event description was forwarded to the supplier osartis / aap.We now are in receipt of the investigation result: we have analyzed retain samples of the affected batch in our laboratory without any deviations.The application testing shows comparable results as for the final control of this batch, all results are within the specified values.Also, the batch and qc documentation of the affected batch shows no deviation.The description of the failure could indicate a temperature issue during conditioning of the cement unit for the procedure.The viscosity of the cement depends strongly from the temperature.The risk assessment for vertecem vplus was reviewed and found to adequately address the harm of this complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7514634
• MDR Text Key: 108271668
• Report Number: 8030965-2018-53765
• 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: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2020
• Device Catalogue Number: 07.702.016S
• Device Lot Number: 7D53203
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR