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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIAMI DEVICE SOLUTIONS LOCKING CAP, 2.7T

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MIAMI DEVICE SOLUTIONS LOCKING CAP, 2.7T Back to Search Results
Model Number MDS100301L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Missing Value Reason (3192)
Event Date 01/11/2018
Event Type  Injury  
Manufacturer Narrative

Weight is unknown. Investigation: visual inspection of the subject device only revealed normal signs of wear and tear. Review of the dhr and ncr files was conducted and there were no findings that could have contribute to this complaint. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

The operating surgeon reported that removal of the subject device and accompanying implants had been scheduled due to crepitus of the fpl tendon. The original surgery took place on (b)(6) 2017. The removal procedure was completed on (b)(6) 2018 with no complications reported. All implants were intact and returned to the manufacturer for evaluation.

 
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Brand NameLOCKING CAP, 2.7T
Type of DeviceLOCKING CAP, 2.7T
Manufacturer (Section D)
MIAMI DEVICE SOLUTIONS
7620 nw 25th st
unit 3
miami beach FL 33122
Manufacturer Contact
anderson giraldo
7620 nw 25th st. unit 3
mimai beach, FL 33122
3057225310
MDR Report Key7230769
MDR Text Key98669612
Report Number3009222247-2018-00003
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK161292
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 01/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/31/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberMDS100301L
Device Catalogue NumberMDS100301L
Device LOT NumberBDK2JSF
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/15/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2018
Was Device Evaluated By Manufacturer? Yes
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: 01/31/2018 Patient Sequence Number: 1
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