FDA.reportPublic FDA data

MAUDE MDR 9555398

MDR report key
9555398
Report number
3007700286-2019-00157
Event key
0
Event type
3
Date of event
2019-12-11
Date received
2020-01-06
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
W. RECKLING, M.D.
Address
471 EL CAMINO REAL SUITE 101 SANTA CLARA CA 95050 US
Phone
408-408-4082
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IFUSE IMPLANT SYSTEMORTHOPEDIC RODSI-BONE, INC.OURUNKNOWNUNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-0601. O

Event Narratives#

N

Patient 1

BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU, CERTIFICATES OF ANALYSIS AND FMEAS, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS USER ERROR; MALPOSITIONING OF THE IMPLANT DURING INSTALLATION AND/OR IMPROPER IMPLANT SIZE SELECTION, USING TOO SHORT OF AN IMPLANT.

D

Patient 1

THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE TWO IMPLANTS WERE PLACED. THE PATIENT LATER REPORTED CONTINUED LEFT SI JOINT PAIN. THE SURGEON DETERMINED THAT THE CAUDAL POSITIONED IMPLANT WAS MALPOSITIONED, TOO DORSAL, AND WAS NOT FULLY ACROSS THE SI JOINT. THE SURGEON DID NOT INDICATE THAT ANY OF THE IMPLANTS WERE LOOSE. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE CAUDAL IMPLANT WITH CHISELS AS IT WAS SOLIDLY FIXED IN BONE. HE ALSO INSTALLED A NEW IMPLANT OF THE SAME TYPE IN A MORE CAUDAL POSITION. THE PATIENT IS DOING WELL FOLLOWING THE REVISION PROCEDURE.