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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SKELETAL DYNAMICS IMPLATE WRIST ARTHRODESIS NAIL SYSTEM

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SKELETAL DYNAMICS IMPLATE WRIST ARTHRODESIS NAIL SYSTEM Back to Search Results
Model Number IMPLATE Nail, Metacarpal, Mini
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Implant Pain (4561)
Event Date 08/05/2021
Event Type  Injury  
Manufacturer Narrative
Complaint part is not expected to be returned for review/investigation. Device lot number was not provided and therefore a thorough review of device records could not be conducted. Attempts made to get additional information were unsuccessful. Based on the limited information available, no conclusion can be drawn. No trend has been identified at the time of this submission. This type of failure mode will continue to be monitored.
 
Event Description
Screw loosening post-op.
 
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Brand NameIMPLATE
Type of DeviceWRIST ARTHRODESIS NAIL SYSTEM
Manufacturer (Section D)
SKELETAL DYNAMICS
7300 n. kendall drive
suite 400
miami FL 33156
Manufacturer (Section G)
SKELETAL DYNAMICS
7300 n. kendall drive
suite 400
miami FL 33156
Manufacturer Contact
mehr malek
7300 n. kendall drive
suite 400
miami, FL 33156
MDR Report Key12457220
MDR Text Key271054982
Report Number3006742481-2021-00008
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092720
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberIMPLATE Nail, Metacarpal, Mini
Device Catalogue NumberIMP-MCN-M40
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 Received08/12/2021
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 Initial

Patient Treatment Data
Date Received: 09/10/2021 Patient Sequence Number: 1
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