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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VLP TI 2.4MM X 22MM CTX SCR T7 S-T PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. VLP TI 2.4MM X 22MM CTX SCR T7 S-T PLATE, FIXATION, BONE Back to Search Results
Catalog Number 74402422
Device Problem Blocked Connection (2888)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/04/2020
Event Type  malfunction  
Event Description
It was reported that during surgery the screws wouldn't lock into plate. Opened a new set and used the contents of that s&n set. No delay reported.
 
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Brand NameVLP TI 2.4MM X 22MM CTX SCR T7 S-T
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks rd.
MDR Report Key10101918
MDR Text Key193132064
Report Number1020279-2020-01903
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132886
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number74402422
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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