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

MAUDE Adverse Event Report: GRAHAM MEDICAL TECHNOLOGIES LLC, DBA GRAMEDICA HYPROCURE; SUBTALAR IMPLANT

  • 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
 

GRAHAM MEDICAL TECHNOLOGIES LLC, DBA GRAMEDICA HYPROCURE; SUBTALAR IMPLANT Back to Search Results
Model Number HYP-06
Device Problems Loose or Intermittent Connection (1371); Insufficient Information (3190)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/03/2017
Event Type  Injury  
Manufacturer Narrative
A multicenter post market clinical follow-up retrospective study is being performed at specific time points post-implantation to evaluate the safety and performance of the hyprocure implant.The pmcf studies were not requested by fda.The manufacturer was not made aware of these issues prior to the report study and no complaints have been made.The device instructions for use includes a warning - it is very important to selct the correct size of the implant to achieve the best possible correction.All risks have been reduced as low as possible.
 
Event Description
Migration.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HYPROCURE
Type of Device
SUBTALAR IMPLANT
Manufacturer (Section D)
GRAHAM MEDICAL TECHNOLOGIES LLC, DBA GRAMEDICA
16137 leone drive
macomb MI 48042
Manufacturer (Section G)
GRAHAM MEDICAL TECHNOLOGIES, LLC DBA GRAMEDICA
16137 leone drive
macomb MI 48042
Manufacturer Contact
angela recchia
16137 leone drive
macomb, MI 48042
5866779600
MDR Report Key11852044
MDR Text Key251672089
Report Number3004993707-2021-00025
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation Other
Type of Report Initial
Report Date 04/12/2021
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
Device Operator Health Professional
Device Expiration Date07/16/2021
Device Model NumberHYP-06
Device Catalogue NumberHYP-06
Device Lot Number060523161
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/21/2021
Initial Date FDA Received05/19/2021
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 Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age48 YR
-
-