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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRUM AB FIXTURE BIOHELIX 23X80 -12
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INTEGRUM AB FIXTURE BIOHELIX 23X80 -12 Back to Search Results
Model Number 1811
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/19/2018
Type of Reportable Event Serious Injury
Event or Problem Description
Fixture loosening.No deviation in batch documentation.According to report form the cause of failure is unknown.No further investigation.
 
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Brand Name
FIXTURE BIOHELIX 23X80 -12
Common Device Name
FIXTURE BIOHELIX 23X80 -12
Manufacturer (Section D)
INTEGRUM AB
krokslatts fabriker 50
molndal, vastra gotaland 43137
SW  43137
MDR Report Key8048127
Report Number3011386779-2018-00012
Device Sequence Number1786927
Product Code PJY
UDI-Device Identifier07340152100283
UDI-Public07340152100283
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
H080004
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Remedial Action Patient Monitoring
Type of Report Initial
Report Date (Section B) 11/06/2018
Report Date (Section F) 07/17/2018
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? No
Operator of Device Lay User/Patient
Device Expiration Date08/01/2021
Device Model Number1811
Device Catalogue Number1811
Device Lot NumberP266262
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/19/2018
Device Age17 MO
Event Location Hospital
Date Report to Manufacturer07/17/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/17/2018
Initial Report FDA Received Date11/07/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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