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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 5.0MM CANNULATED LOCKING SCREW 70MM; SCREW, FIXATION, BONE
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5.0MM CANNULATED LOCKING SCREW 70MM; SCREW, FIXATION, BONE Back to Search Results
Model Number 02.205.070
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Additional product codes: hty, jdw, hrs.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Corrections to information captured on user facility report.Complainant part is not expected to be returned for manufacturer review/investigation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
 
Event or Problem Description
This report is against user facility medwatch number (b)(4), a copy is attached.The only information contained in this report is correction or additional information.This report captures one cannulated locking screw.The other screws and plate are being captured on related complaint (b)(4).This is report 1 of 1 for (b)(4).
 
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Brand Name
5.0MM CANNULATED LOCKING SCREW 70MM
Common Device Name
SCREW, FIXATION, BONE
MDR Report Key7495236
Report Number2939274-2018-52063
Device Sequence Number239193
Product Code HWC
UDI-Device Identifier10886982049766
UDI-Public(01)10886982049766
Combination Product (Y/N)N
PMA/510(K) Number
K000066
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/17/2018
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? No
Operator of Device No Information
Device Model Number02.205.070
Device Catalogue Number02.205.070
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/17/2018
Initial Report FDA Received Date05/08/2018
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 Required Intervention;
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