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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS PYRAMESH C TITANIUM MESH; MESH, METAL
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WARSAW ORTHOPEDICS PYRAMESH C TITANIUM MESH; MESH, METAL Back to Search Results
Catalog Number 905-137
Medical Device Problem Codes Break (1069); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Implanted date: only year valid.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported as per a litigation complaint that on an unknown date in 2013, the patient underwent a surgery due to cervical injury caused from an accident in the school.Allegedly, a cervical vertebra was surgically implanted.On an unknown date, post-op, the implant was found broken and loosened.No more information is available now.
 
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Brand Name
PYRAMESH C TITANIUM MESH
Common Device Name
MESH, METAL
Manufacturer (Section D)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
MDR Report Key9500883
Report Number1030489-2019-01445
Device Sequence Number19130005
Product Code EZX
UDI-Device Identifier00673978080659
UDI-Public00673978080659
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K011406
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Manufacturer
Report Source consumer,foreign
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number905-137
Device Lot Number0250974W
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/19/2019
Initial Report FDA Received Date12/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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