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U.S. Department of Health and Human Services

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

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PARAGON 28, INC. BABY GORILLA/GORILLA PLATING SYSTEM BONE PLATE Back to Search Results
Model Number P53-103-L052
Device Problems Break (1069); Appropriate Term/Code Not Available (3191)
Patient Problems Failure of Implant (1924); Injury (2348); Impaired Healing (2378)
Event Date 08/14/2017
Event Type  Injury  
Manufacturer Narrative

Case information including facility information was not provided by the initial reporter. The review of the device history records of the plate used during the surgery indicate that the device was manufactured according to specification and no deviations were noted for released product. 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 surgical procedure on (b)(6) 2016 that utilized a paragon 28 gorilla plating system. A medium mtp plate was used to address the bunion deformity with a mix of 3. 5mm locking and non-locking screw and a 4. 0mm screw as a crossing screw. The patient was said to be doing well on (b)(6) 2016 appointment. However, around (b)(6) 2016, patient reported sustaining an injury on the toe while on vacation. The patient improved with a stiff shoe however, she reported increased nerve pain in (b)(6) 2017. A ct scan was completed and showed the arthrodesis had not fully healed. At about 6 months post-operatively, an x-ray revealed the 4. 0mm screw to be backed out plantarly and the plate broken. The plate broke proximally to the jig holes and directly across the joint. A revision surgery was completed on (b)(6) 2017 to remove the broken hardware and a thicker paragon 28 plate was used. Patient was said to be complaint to post-operative instructions. The post-operative protocol was 6 weeks heel weight bearing, then 2 weeks full weight bearing in a short boot with transition into stiff shoe or clog at 8 weeks post-operative this is report 2 of 2 for the incident. This report is to address the broken mtp plate.

 
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Brand NameBABY GORILLA/GORILLA PLATING SYSTEM
Type of DeviceBONE PLATE
Manufacturer (Section D)
PARAGON 28, INC.
14445 grasslands dr.
englewood CO 80112
Manufacturer Contact
victoria akinboboye
14445 grasslands dr.
englewood, CO 80112
7206431300
MDR Report Key10834487
MDR Text Key216099780
Report Number3008650117-2020-00137
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 11/12/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberP53-103-L052
Device Catalogue NumberP53-103-L052
Device LOT NumberJP0005
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/01/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2017
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: 11/13/2020 Patient Sequence Number: 1
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