Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOHORIZONS, INC. BIOHORIZONS INTERNAL 3.5 MM CUSTOM CAST ABUTMENT, HEXED; INTERNAL 3.5MM CUSTOM CAST ABUTMENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOHORIZONS, INC. BIOHORIZONS INTERNAL 3.5 MM CUSTOM CAST ABUTMENT, HEXED; INTERNAL 3.5MM CUSTOM CAST ABUTMENT Back to Search Results
Model Number PYCAH
Device Problem Fitting Problem (2183)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The return device did not include the hex.The product returned was fractured.The bevel of the abutment where the hex would seat onto the implant has been comprised.The comprise possible occurred during prepping which resulted in the failure of the prosthesis.
 
Event Description
The abutment is not seating properly on the implant.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BIOHORIZONS INTERNAL 3.5 MM CUSTOM CAST ABUTMENT, HEXED
Type of Device
INTERNAL 3.5MM CUSTOM CAST ABUTMENT
Manufacturer (Section D)
BIOHORIZONS, INC.
2300 riverchase center
birmingham AL 35244
Manufacturer (Section G)
BIOHORIZONS, INC.
2300 riverchase center
birmingham AL 35244
Manufacturer Contact
anissa smith
2300 riverchase center
birmingham, AL 35244
2059867888
MDR Report Key7390563
MDR Text Key104271347
Report Number1060818-2018-00015
Device Sequence Number1
Product Code NDP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 04/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberPYCAH
Device Catalogue NumberPYCAH
Device Lot Number1504008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2018
Was the Report Sent to FDA? No
Date Manufacturer Received02/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-