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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEWDEAL SAS TTC PLATE - 9 HOLES - RIGHT N/A

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NEWDEAL SAS TTC PLATE - 9 HOLES - RIGHT N/A Back to Search Results
Catalog Number 181004SND
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device is not expected to be returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
On (b)(6) 2019, a sales representative received a call from a physician who reported an issue with a tcc plate (9 holes-right / product id (b)(6)). Two of the calcaneus screws backed out as well as the locking caps. The physician will see the patient again to determine what additional actions are required as far as if a removal is needed.
 
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Brand NameTTC PLATE - 9 HOLES - RIGHT
Type of DeviceN/A
Manufacturer (Section D)
NEWDEAL SAS
97 allee alexandre borodine
97 allee alexandre borodine
saint priest 69800
FR 69800
Manufacturer (Section G)
NEWDEAL SAS
97 allee alexandre borodine
parc tech de laporte des alpes
saint priest 69800
FR 69800
Manufacturer Contact
vivian nelson
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key8491093
MDR Text Key141190192
Report Number9615741-2019-00006
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K073375
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number181004SND
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 Received07/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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