FDA.reportPublic FDA data

MAUDE MDR 9558069

MDR report key
9558069
Report number
3007700286-2019-00161
Event key
0
Event type
3
Date of event
2019-12-16
Date received
2020-01-07
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
12020-01-0701. O

Event Narratives#

N

Patient 1

BASED ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU 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 IMPLANT LATE LOOSENING.

D

Patient 1

THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE INITIAL PROCEDURE DATE IS NOT KNOWN. THE PATIENT HAD GOOD INITIAL PAIN RELIEF BEFORE REPORTING A RECURRENCE OF RIGHT SIDE SI JOINT PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE SUPERIOR AND MIDDLE IMPLANTS MAY HAVE BEEN LOOSE. THE SURGEON DID NOT INDICATE THAT ANY OF THE IMPLANTS WERE MALPOSITIONED. IN (B)(6) 2019, THE SURGEON REMOVED THE RIGHT SIDE SUPERIOR POSITIONED IMPLANT AND REPLACED IT WITH A NEW IMPLANT OF THE SAME TYPE PACKED WITH BONE GRAFT. HE THEN ADDED AN ADDITIONAL IMPLANT OF THE SAME TYPE IN A MORE VENTRAL POSITION. THE INFERIOR POSITIONED IMPLANT WAS NOT ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.