MAUDE Adverse Event Report: AAP BIOMATERIALS GMBH & CO. KG SIMPLEX HC US 1 PACK; SIMPLEX HV BONE CEMENT

Model Number SIMPLEX HV US

Device Problems Failure To Unwrap (2940); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2014

Event Type  malfunction  

Event Description

During surgery packaging on simplex hv was not tearing appropriately to be able to remove the inner powder pouch in a sterile manner.

• Brand Name: SIMPLEX HC US 1 PACK
• Type of Device: SIMPLEX HV BONE CEMENT
• Manufacturer (Section D): AAP BIOMATERIALS GMBH & CO. KG; lagerstrasse 11-15; dieburg 6480 7; GM 64807
• Manufacturer Contact: lydia heimann ; lagerstrasse 11-15; dieburg 64807 ; GM 64807 ; 071929107
• MDR Report Key: 4217149
• MDR Text Key: 5077060
• Report Number: 9615014-2014-00005
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2015
• Device Model Number: SIMPLEX HV US
• Device Catalogue Number: 6194-1-001
• Device Lot Number: 316AA876EU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1