FDA.reportPublic FDA data

MAUDE MDR 9703670

MDR report key
9703670
Report number
3008650117-2020-00006
Event key
0
Event type
3
Date received
2020-02-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MACKENZIE BELDEN
Address
14445 GRASSLANDS DR. ENGLEWOOD, CO US
Phone
643-643-6431
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HAMMERTUBE SYSTEMINTERPHALANGEAL IMPLANTPARAGON 28, INC.HTYR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-1201. R

Event Narratives#

N

Patient 1

DEVICES ARE NOT EXPECTED TO BE RETURNED FOR THE MANUFACTURER REVIEW/INVESTIGATION. IDENTIFYING INFORMATION, SUCH AS THE PART NUMBER OR LOT NUMBER OF THE PLATES, WAS NOT REPORTED TO PARAGON 28. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

D

Patient 1

DURING POST-MARKET SURVEILLANCE ACTIVITIES, PARAGON 28 BECAME AWARE THAT A PARAGON 28 HAMMERTUBE IMPLANT BROKE POST-OPERATIVELY AND WAS REVISED. IT WAS REPORTED THAT THE HAMMERTUBE BREAK WAS CAUSED BY A LACK OF SOFT TISSUE RELEASE WITHIN THE AREA. THE SURGEON USED A 2.0MM SCREW TO REVISE THE JOINT.