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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC. BABY GORILLA/GORILLA PLATING SYSTEM MORSELIZING BONE GRAFT HARVESTER

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PARAGON 28, INC. BABY GORILLA/GORILLA PLATING SYSTEM MORSELIZING BONE GRAFT HARVESTER Back to Search Results
Model Number P99-930-2108
Device Problems Patient-Device Incompatibility (2682); Device-Device Incompatibility (2919); Difficult to Advance (2920)
Patient Problem Burn, Thermal (2530)
Event Date 10/18/2019
Event Type  Injury  
Manufacturer Narrative

Identifying information, such as the lot number of the device was not reported to paragon 28. Case information including related patient information was not provided by the initial reporter. Devices are not expected to be returned for the manufacturer review/investigation. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.

 
Event Description

It was reported that the patient underwent a primary fusion surgical procedure that utilized paragon 28 morselizing bone graft harvester, ao, 8mm. The bone graft harvester burned the patient's bone while harvesting from the left calcaneus. It was reported that a 2. 3 x 150 mm k-wire single ended trocar was used however, the complaint initiator mentioned that k-wire did not make a large enough entrance hole. Alleging that the usage of the k-wire made it difficult to push through which then resulted into the burning of the bone graft.

 
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Brand NameBABY GORILLA/GORILLA PLATING SYSTEM
Type of DeviceMORSELIZING BONE GRAFT HARVESTER
Manufacturer (Section D)
PARAGON 28, INC.
14445 grasslands dr.
englewood CO 80112
Manufacturer Contact
victoria akinboboye
14445 grasslands dr.
englewood, CO 80112
MDR Report Key11356980
MDR Text Key232801958
Report Number3008650117-2021-00032
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK190365
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 02/21/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/22/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberP99-930-2108
Device Catalogue NumberP99-930-2108
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2019
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: 02/22/2021 Patient Sequence Number: 1
Treatment
2.3 X 150 MM K-WIRE SINGLE ENDED TROCAR; DISPOSABLE TREPHINE; REUSABLE DOOR
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