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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LINVATEC CORPORATION D/B/A CONMED LINVATEC Y-KNOT ALL SUTURE ANCHOR (LINVATEC); FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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LINVATEC CORPORATION D/B/A CONMED LINVATEC Y-KNOT ALL SUTURE ANCHOR (LINVATEC); FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Unspecified Infection (1930); Inflammation (1932)
Event Date 07/16/2020
Event Type  Injury  
Event Description
Parametrics medical distributed two dermis on demand allografts ((b)(4) serial numbers (b)(4)) to the center for ambulatory surgery center on (b)(6) 2020.Both allografts were implanted during a shoulder repair by dr.(b)(6) on (b)(6) 2020.The following were also implanted during the procedure: y-knot suture anchors (linvatec) x 3 and healix advance sp anchors (mitek 222425, lot 6l19804) x2.On (b)(6) 2020 the patient was brought back to the operating room to remove all the hardware due to an infection.The incision was open and red, and the tissue was inflamed deep down to the repair and bone.All hardware was removed, minus the tip of the healix advance sp dilator tips.The patient was admitted to the hospital to continue antibiotics overnight.Parametrics medical received the complaint notification on 07-17-2020 and notified (b)(6) on 07-20-2020.At this time no additional information regarding the patient or allografts could be obtained following multiple attempts.
 
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Brand Name
Y-KNOT ALL SUTURE ANCHOR (LINVATEC)
Type of Device
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Manufacturer (Section D)
LINVATEC CORPORATION D/B/A CONMED LINVATEC
MDR Report Key10459227
MDR Text Key204716912
Report NumberMW5096290
Device Sequence Number3
Product Code MBI
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/24/2020
5 Devices were Involved in the Event: 1   2   3   4   5  
1 Patient was Involved in the Event
Date FDA Received08/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Is the Reporter a Health Professional? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Weight90
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