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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US VLIFT EXPANDER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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STRYKER SPINE-US VLIFT EXPANDER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number 48300200
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Codes No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event 01/26/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the inner shaft of the expander broke during surgery.The surgeon was able to remove the broken tip from the cage and complete the case with no issues for the patient.
 
Event or Problem Description
It was reported that the inner shaft of the expander broke during surgery.The surgeon was able to remove the broken tip from the cage and complete the case with no issues for the patient.
 
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Brand Name
VLIFT EXPANDER
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
MDR Report Key7285212
Report Number0009617544-2018-00049
Device Sequence Number1368109
Product Code LXH
UDI-Device Identifier07613327266986
UDI-Public(01)07613327266986
Combination Product (Y/N)N
Initial Reporter CountryGB
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 05/11/2018
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 Model Number48300200
Device Catalogue Number48300200
Device Lot Number153308
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2018
Initial Date Received by Manufacturer 01/27/2018
Supplement Date Received by Manufacturer04/19/2018
Initial Report FDA Received Date02/21/2018
Supplement Report FDA Received Date05/11/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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