• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET BIOLOGICS UNKNOWN TISSUE

  • 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
 

BIOMET BIOLOGICS UNKNOWN TISSUE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 09/29/2016
Event Type  Injury  
Manufacturer Narrative
The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. Event is being reported to fda on one medwatch since the limited information available indicates that a revision procedure may occur. Should additional information be received regarding a revision procedure, the complaint will be reassessed and, if warranted, further medwatch reports will be submitted.
 
Event Description
Patient has been indicated for a future revision due to allograft failure. No additional information has been provided.
 
Manufacturer Narrative
This follow-up report is being filed to correct information.
 
Event Description
Patient has been indicated for a future revision due to allograft failure. However, no revision procedure has been reported to date. No additional information has been provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN TISSUE
Manufacturer (Section D)
BIOMET BIOLOGICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
megan haas
56 e. bell drive
warsaw, IN 46582
5743726700
MDR Report Key5889940
MDR Text Key52561236
Report Number0001825034-2016-03183
Device Sequence Number1
Product Code NUN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/19/2016 Patient Sequence Number: 1
-
-