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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANATOMAGE INC. ANATOMAGE INC.; SURGICAL GUIDE

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ANATOMAGE INC. ANATOMAGE INC.; SURGICAL GUIDE Back to Search Results
Device Problem Material Fragmentation (1261)
Patient Problem No Code Available (3191)
Event Date 01/02/2018
Event Type  malfunction  
Manufacturer Narrative
Implant site #23 was the weakest point of the guide due to less coverage.Doctor might have applied too much pressure on the guide when a tissue punch was being done through it.As a result, guide fractured from site #23.
 
Event Description
When doctor was performing a tissue punch through the guide at site 23, the sleeve popped out and the guide fractured.
 
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Brand Name
ANATOMAGE INC.
Type of Device
SURGICAL GUIDE
Manufacturer (Section D)
ANATOMAGE INC.
303 almaden blvd.
suite 700
san jose CA 95110
Manufacturer (Section G)
ANATOMAGE INC.
303 almaden blvd.
suite 700
san jose CA 95110
Manufacturer Contact
meera savaliya
303 almaden blvd.
suite 700
san jose 95110
4088851474
MDR Report Key7470880
MDR Text Key106873903
Report Number3008272529-2018-00015
Device Sequence Number1
Product Code NDP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial
Report Date 01/10/2018
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
Device Operator Other
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/10/2018
Initial Date FDA Received04/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/26/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age50 YR
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