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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND UC VELYS ARRAY CLAMP ORTHOPEDIC STEREOTAXIC INSTRUMENT

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DEPUY IRELAND UC VELYS ARRAY CLAMP ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 4515-70-107
Device Problems Appropriate Term/Code Not Available (3191); Premature Separation (4045)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2021
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. The reporter was not able to provide the associated lot number for this event so the lot numbers provided were j43052 and j43054 and it is unknown which of the two devices is associated with the reported event.
 
Event Description
It was reported that during surgery that the array clamp device disassociated from the array. It was also reported that the array clamp appeared to have loosened. It was reported that there was a 40 minute surgical delay. It was reported that the user went to manual instrumentation following the event. There were no reports of medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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Brand NameVELYS ARRAY CLAMP
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
DEPUY IRELAND UC
loughbeg ringaskiddy co.
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthpaedic dr.
warsaw, IN 46581
6107428552
MDR Report Key12805026
MDR Text Key280705480
Report Number1818910-2021-24965
Device Sequence Number1
Product Code OLO
UDI-Device Identifier10603295519379
UDI-Public10603295519379
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K202769
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 03/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4515-70-107
Device Catalogue Number451570107
Device Lot NumberJ43052
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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