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

Model Number	HYP-07
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/21/2016
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
The device has not corrected the problem.

• Brand Name: HYPROCURE
• Common Device Name: HYPROCURE SUBTALAR IMPLANT
• Manufacturer (Section D): GRAHAM MEDICAL TECHNOLOGIES, LLC. DBA GRAMEDICA; 16137 leone drive; macomb MI 48042
• MDR Report Key: 11852035
• Report Number: 3004993707-2021-00021
• Device Sequence Number: 3747424
• Product Code: HWC
• UDI-Device Identifier: M621HYP070
• UDI-Public: M621HYP070
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K042030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 11/22/2020
• Device Model Number: HYP-07
• Device Catalogue Number: HYP-07
• Device Lot Number: 070323153
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2021
• Initial Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 10 YR