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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: I.T.S. GMBH HALLUX OSTEOTOMY PLATE HOL

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I.T.S. GMBH HALLUX OSTEOTOMY PLATE HOL Back to Search Results
Model Number 21015-08
Device Problem Device Issue (2379)
Patient Problem Missing Value Reason (3192)
Event Date 05/26/2017
Event Type  Malfunction  
Manufacturer Narrative

Due to lack of information of the incident and the product itself, the last quality inspection documents, including the material certificates of the hallux osteotomy plate and the locking screw were checked and no deviation was found. We have send a request to the distribution partner to gain more information of the incident. We have not received the product back.

 
Event Description

Concerning the complaint form we have received from our distributor, a d=3. 0mm cancellous screw has not locked in a hallux osteotomy plate. Due to this another screw was used to finish the surgery.

 
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Brand NameHALLUX OSTEOTOMY PLATE
Type of DeviceHOL
Manufacturer (Section D)
I.T.S. GMBH
autal 28
lassnitzhoehe, styria 8301
AU 8301
Manufacturer (Section G)
I.T.S. GMBH
autal 28
lassnitzhöhe, styria 8301
AU 8301
Manufacturer Contact
florian grill
autal 28
lassnitzhöhe, styria 8301
AU   8301
3316211214
MDR Report Key6669551
MDR Text Key78579604
Report Number3004369035-2017-00002
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial
Report Date 06/27/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number21015-08
Device Catalogue Number21015-08
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2017
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?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 06/27/2017 Patient Sequence Number: 1
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