MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.Event year reported as 2018; exact date is unknown.This report is for an unknown traumacem biomaterial cement.Part and lot numbers are unknown.Without the specific part and lot number, the udi is not available.Implanted in 2018, however exact date is unknown.Cement remained implanted, as such explant date is not applicable.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter¿s phone number is not provided for reporting.(510k): unknown, as specific part and lot numbers for traumacem biomaterial cement is not provided.(b)(4) used to capture additional medical/surgical intervention required: the cement hardened too quickly preventing the injection device from being removed.Without a lot number the device history records review could not be completed.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 that during augmentation of tfn-advanced¿ proximal femoral nailing system (tfna), the traumacem cement hardened quite fast.Because of this it was impossible to remove the cement cannula.It broke and a part of the cannula remained in the blade.No other information provided.Concomitant device reported: blade (part # unknown, lot # unknown, quantity 1).This report is for an unknown traumacem biomaterial cement.This is report 1 of 2 for complaint (b)(4).

• Type of Device: POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7479403
• MDR Text Key: 107105220
• Report Number: 8030965-2018-53492
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention