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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; SUP/POST AUG PLATE, R RS GLENOID BASEPLATE

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EXACTECH, INC. EQUINOXE; SUP/POST AUG PLATE, R RS GLENOID BASEPLATE Back to Search Results
Catalog Number 320-15-08
Device Problems Loose or Intermittent Connection (1371); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Failure of Implant (1924); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
This event report was received through clinical data collection activities.Pending evaluation.
 
Event Description
Index surgery: (b)(6) 2016.Aseptic glenoid loosening.The case report form indicates this event is possibly related to devices and possibly related to procedure.
 
Manufacturer Narrative
Section h10: (a1) patient identifier (in confidence): (b)(6).(b2) outcomes attributed to adverse event: added check for hospitalization - initial or prolonged.(d4) catalog number: 320-15-08, serial number: (b)(6), expiration date: 20-sep-2026, unique identifier (udi) #: (b)(4).(e3) occupation: physician.(g5) pma/510(k)number: k131575.(h4) device manufacture date: 20-sep-2016.(h7) evaluation codes: 1924, 4002.Section h11: *the following sections have corrected information: (d1) brand name: equinoxe.(d2) common device name: sup/post aug plate, r rs glenoid baseplate.(e1) initial reporter name: dr.(b)(6).(e2) health professional?: yes.(g1) mdr reporting contact name: (b)(4).(g3) report source: health professional.(h3) the glenoid baseplate loosening reported was likely the result of the screw(s) fracturing.The underlying cause of the screw fracture is unknown but may have been the result of the reported patient fall.However, this cannot be confirmed as the devices have not been revised and, therefore, are not available for evaluation, and no further information was provided.*no information provided in the following section(s): b6, b7, d7, g8, h7, h9.
 
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Brand Name
EQUINOXE
Type of Device
SUP/POST AUG PLATE, R RS GLENOID BASEPLATE
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key8304751
MDR Text Key134993157
Report Number1038671-2019-00046
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
PMA/PMN Number
K131575
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/27/2020
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 Catalogue Number320-15-08
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/28/2019
Initial Date FDA Received02/05/2019
Supplement Dates Manufacturer Received02/26/2020
Supplement Dates FDA Received02/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age69 YR
Patient Weight144
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