MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TRAUMACEM(TM) V+ INJECTABLE BONE CEMENT - STERILE; POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT

Catalog Number 07.702.040S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.Device malfunctioned intra-operatively and was not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during an unknown surgical procedure on (b)(6) 2018, the traumacem v+ injectable bone cement hardened too quickly.As a result, it could not be used.This report is for one (1) traumacem v+ injectable bone cement.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

A device history record (dhr) review was conducted for part number: 07.702.040s, synthes lot number: 7d53202: release to warehouse date: 21.Aug.2017 expiry date:01.April 2020, manufacturing site: (b)(4): no non-conformance reports (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.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: TRAUMACEM(TM) V+ INJECTABLE BONE CEMENT - STERILE
• Type of Device: POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7462350
• MDR Text Key: 106592366
• Report Number: 8030965-2018-53360
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 07611819453425
• UDI-Public: (01)07611819453425
• Combination Product (y/n): N
• PMA/PMN Number: K170802
• 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: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2020
• Device Catalogue Number: 07.702.040S
• Device Lot Number: 7D53202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1