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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK UNKNOWN ANCHOR UNKNOWN MITEK IMPLANTS

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DEPUY MITEK UNKNOWN ANCHOR UNKNOWN MITEK IMPLANTS Back to Search Results
Catalog Number UNK BONE ANCHOR
Device Problem Insufficient Information (3190)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
Mitek medical safety department discovered this published white paper detailing a historical event in which some mitek devices were implicated. Two patients had a re-surgery to remove anchor fragments. It cannot be confirmed that this issue had been previously reported to mitek, so an adverse event report is being filed to document the experience described in the article. The author has been contacted to obtain further information but no response was received. At this point in time, no further action is warranted. However, this file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue. Mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field. Udi - unavailable. The product details are not available. Associated medwatch: 1221934-2017-10142.
 
Event Description
This report is being filed after the subsequent review of the following article: arthroscopic suture-bridge repair for small to medium size supraspinatus tear: healing rate and retear pattern. Authors: neyton lionel m. D. And "et al" arthroscopy: the journal of arthroscopic and related surgery, vol 29, no 1 (january), 2013: pp 10-17 shoulder unit and radiology unit. (b)(6). N
=
2 2 patients needed anchor fragments removed.
 
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Brand NameUNKNOWN ANCHOR
Type of DeviceUNKNOWN MITEK IMPLANTS
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
jennifer lawrence
325 paramount drive
raynham, MA 02767
5089776860
MDR Report Key6474438
MDR Text Key72194378
Report Number1221934-2017-10143
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK BONE ANCHOR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Report to Manufacturer03/09/2017
Date Manufacturer Received03/09/2017
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/08/2017 Patient Sequence Number: 1
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