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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUTE INNOVAITONS LLC BIOBRIDGE RESORBABLE CHEST WALL STABILIZATION PLATE BIOBRIDGE PLATE

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ACUTE INNOVAITONS LLC BIOBRIDGE RESORBABLE CHEST WALL STABILIZATION PLATE BIOBRIDGE PLATE Back to Search Results
Model Number BIOBRIDGE
Device Problem No Apparent Adverse Event (3189)
Patient Problem Missing Value Reason (3192)
Event Date 01/08/2019
Event Type  Injury  
Event Description

Per the surgeon who performed the initial surgery it is understood that the patient had developed seroma, which is not uncommon to develop post surgery. The patient contacted acute with questions regarding "infection" and the plate's nature to withhold. The patient consulted a plastic surgeon rather than the surgeon who performed the initial surgery. The patient had the "infection"/seroma drained by the plastic surgeon and the plates (which were implanted in small pieces in the first place) also got drained.

 
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Brand NameBIOBRIDGE RESORBABLE CHEST WALL STABILIZATION PLATE
Type of DeviceBIOBRIDGE PLATE
Manufacturer (Section D)
ACUTE INNOVAITONS LLC
8055 ne jacobson street
suite 700
hillsboro 97124
Manufacturer (Section G)
ACUTE INNOVAITONS LLC
8055 ne jacobson street
suite 700
hillsboro 97124
Manufacturer Contact
subash sankar tamilselvan
8055 ne jacobson street
suite 700
hillsboro 97124
5036867200
MDR Report Key8391303
MDR Text Key137865052
Report Number3005670412-2019-00001
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
PMA/PMN NumberK120163
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Type of Report Initial
Report Date 02/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/05/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberBIOBRIDGE
Device Catalogue NumberRRP1501
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No
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: 03/05/2019 Patient Sequence Number: 1
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