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

MAUDE Adverse Event Report: EXACTECH, INC. ALTEON ALT HA S CLR EXT SZ 7

  • 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
 

EXACTECH, INC. ALTEON ALT HA S CLR EXT SZ 7 Back to Search Results
Catalog Number 190-31-07
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Failure of Implant (1924)
Event Date 12/05/2019
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
As reported, the stem was loose proximally and was removed during a revision. The device is available for return to the manufacturer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameALTEON
Type of DeviceALT HA S CLR EXT SZ 7
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC.
2320 nw 66 ct
gainesville FL 32653
Manufacturer Contact
kate jacobson
3523771140
MDR Report Key9512829
MDR Text Key173319738
Report Number1038671-2019-00618
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162732
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number190-31-07
Device Lot Number80638050
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2020
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

Patient Treatment Data
Date Received: 12/23/2019 Patient Sequence Number: 1
-
-