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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5 X 24MM POLYAXIAL SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS
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STRYKER SPINE-FRANCE OASYS 3.5 X 24MM POLYAXIAL SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS Back to Search Results
Model Number 48552324
Medical Device Problem Codes Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Codes Unspecified Infection (1930); No Known Impact Or Consequence To Patient (2692)
Date of Event 09/26/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that; lateral mass screw fractured on the screw shaft at t1.Update (b)(6): patient came to doctor because of a c5-6 infection.
 
Event or Problem Description
It was reported that; lateral mass screw fractured on the screw shaft at t1.Update 10/02/2017: patient came to doctor because of a c5-6 infection.
 
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Brand Name
OASYS 3.5 X 24MM POLYAXIAL SCREW
Common Device Name
SPINAL INTERLAMINAL FIXATION ORTHOSIS
Manufacturer (Section D)
STRYKER SPINE-FRANCE
zone industrielle de marticot
cestas 33610
FR  33610
MDR Report Key6957424
Report Number0009617544-2017-00379
Device Sequence Number1142150
Product Code KWP
UDI-Device Identifier04546540371737
UDI-Public(01)04546540371737
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K151755
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 12/21/2017
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 No Information
Device Model Number48552324
Device Catalogue Number48552324
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/26/2017
Supplement Date Received by Manufacturer09/26/2017
Initial Report FDA Received Date10/18/2017
Supplement Report FDA Received Date12/21/2017
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 Required Intervention;
Patient Weight91
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