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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0

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EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 Back to Search Results
Catalog Number 320-10-00
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Ossification (1428)
Event Date 08/31/2018
Event Type  Injury  
Manufacturer Narrative
This event report was received through clinical data collection activities.Pending evaluation.
 
Event Description
Index surgery: (b)(6) 2018.Revision due to heterotopic ossification.The case report form indicates this event is definitely not related to devices and possibly related to procedure.
 
Manufacturer Narrative
The engineering evaluation noted that the revision reported was likely the result of heterotropic ossification.However, this cannot be confirmed as the devices were not available for evaluation and no further information was provided.
 
Manufacturer Narrative
D4: added serial number (b)(4).
 
Manufacturer Narrative
Section h10: (a1) patient identifier (in confidence): (b)(6).(b2) added check for hospitalization - initial or prolonged.(d4) expiration date: 08-may-2028, unique identifier (udi) #: (b)(4).(d5) operator of device: health_care_professional.(d6) if implanted, give date: (b)(6) 2018.(d7) if explanted, give date: (b)(6) 2018.(g5) pma/510(k)number: k063569.(h3) patient was revised on (b)(6) 2018.Only the tray, liner and glenosphere were replaced.(h4) device manufacture date: 09-may-2018.(h5) labeled for single use?: yes.Section h11: corrections made in the following section(s): (e1) initial reporter: dr.(b)(6).(e2) health professional?: yes.(e3) occupation: physician.(e4) initial reporter also sent report to fda?: no.(g1) mdr reporting contact: (b)(6).(g3) report source: health professional.
 
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Brand Name
EQUINOXE
Type of Device
EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key8310046
MDR Text Key135155083
Report Number1038671-2019-00049
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
PMA/PMN Number
K063569
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 11/22/2019
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 Number320-10-00
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/17/2019
Initial Date FDA Received02/06/2019
Supplement Dates Manufacturer Received01/17/2019
01/17/2019
10/30/2019
Supplement Dates FDA Received03/12/2019
07/09/2019
11/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age68 YR
Patient Weight88
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