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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS VENTURE ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
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WARSAW ORTHOPEDICS VENTURE ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Back to Search Results
Catalog Number 9790035
Medical Device Problem Code Migration or Expulsion of Device (1395)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
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 that the patient underwent anterior cervical discectomy and fusion (acdf) from c5-c7 with plate and screws.Post-op, locking mechanism on the implanted plate failed to prevent a screw from backing through it slightly.No additional surgery was performed as a result of this event yet.No patient symptoms or complications were reported as a result of this event.
 
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Brand Name
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
Common Device Name
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Manufacturer (Section D)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
MDR Report Key8530469
Report Number1030489-2019-00440
Device Sequence Number1846506
Product Code KWQ
UDI-Device Identifier00721902988998
UDI-Public00721902988998
Combination Product (Y/N)N
Initial Reporter CountryNZ
PMA/510(K) Number
K042922
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/19/2019
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 Number9790035
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/20/2019
Initial Report FDA Received Date04/19/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
SCREWS
Patient Age49 YR
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