FDA.reportPublic FDA data

MAUDE MDR 9610266

MDR report key
9610266
Report number
9610905-2020-00002
Event key
0
Event type
3
Date of event
2020-01-03
Date received
2020-01-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. JENNIFER DAMATO
Address
P.O. BOX 16369 JACKSONVILLE FL 32245 US
Phone
904-904-9046
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IPSIPS PEEKKARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KGGXN60-000-19-09UNKNOWNY N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-2101. O

Event Narratives#

N

Patient 1

(B)(4). REFERENCE EXEMPTION NUMBER E2017029. AN INVESTIGATION WAS PERFORMED ON THE BASIS OF COMPLAINT STATISTICS AS NO DEVICE WAS RETURNED FOR EVALUATION. THE FAILURE ROOT CAUSE CANNOT BE DETERMINED DUE TO THE DEVICE NOT BEING RETURNED. BASED ON THE INFORMATION PROVIDED THE MOST LIKELY ROOT CAUSE IS PATIENT CONDITION. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.

D

Patient 1

IT WAS REPORTED THAT THE IMPLANT WAS REMOVED TO ADDRESS PATIENT INFECTION.