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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOXED INCISOR PLUS BL,(BX6) SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. BOXED INCISOR PLUS BL,(BX6) SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7205345
Device Problem Material Disintegration (1177)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/14/2017
Event Type  malfunction  
Manufacturer Narrative
Examination was not possible, as the device was not returned. The investigation was limited to the information provided. The investigation could not draw any conclusions about the reported event. No further investigation is warranted at this time. A review of the device history record was performed which confirmed no inconsistencies.
 
Event Description
It was reported that the incisor plus shed. A backup was available to complete the procedure without delay in the case or patient injury reported. Debris was flushed out of the patient.
 
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Brand NameBOXED INCISOR PLUS BL,(BX6)
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer Contact
jim gonzales
7000 west william cannon drive
building 1.
austin, TX 78735
MDR Report Key6697195
MDR Text Key141603944
Report Number1219602-2017-00723
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2022
Device Catalogue Number7205345
Device Lot Number50644641
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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