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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS PIVOX OBLIQUE LATERAL SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
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WARSAW ORTHOPEDICS PIVOX OBLIQUE LATERAL SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Back to Search Results
Catalog Number 2140140
Medical Device Problem Code Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product was not 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 patient was pre-operatively diagnosed with non union and broken rods at this level and underwent oblique lumbar interbody fusion.Post op, the screw subsided to the left about 10-20 mm off the bone.As a result pain was observed in the patient.Fusion was not achieved.
 
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Brand Name
PIVOX OBLIQUE LATERAL SPINAL SYSTEM
Common Device Name
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Manufacturer (Section D)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
MDR Report Key7208848
Report Number1030489-2018-00095
Device Sequence Number13749388
Product Code KWQ
UDI-Device Identifier00643169634787
UDI-Public00643169634787
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K152277
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/22/2018
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? Yes
Operator of Device Health Professional
Device Catalogue Number2140140
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/28/2017
Initial Report FDA Received Date01/22/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age74 YR
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