FDA.reportPublic FDA data

MAUDE MDR 5903427

MDR report key
5903427
Report number
3004485144-2016-00196
Event key
0
Event type
3
Date of event
2016-06-14
Date received
2016-08-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. MICHELLE COLE
Address
310 INTERLOCKEN PARKWAY SUITE 120 BROOMFIELD CO 80021 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SPF-PLUS IMPLANTABLE STIMULATORSPFBIOMET SPINE - BROOMFIELDLOEN/A10-1398M407907R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-08-2501. H; 2. O

Event Narratives#

N

Patient 1

THE PHYSICIAN'S MANUAL STATES "THE GENERATOR MAY OPTIONALLY BE REMOVED AT THE END OF ITS USEFUL LIFE (APPROXIMATELY 24-WEEKS)." THE FULL PRESCRIBING INFORMATION STATES "INDICATIONS:THE SPF PLUS-MINI IMPLANTABLE FUSION STIMULATOR IS INDICATED AS A SPINAL FUSION ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS IN 1 OR 2 LEVELS. THE SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATORS ARE INDICATED AS A SPINAL FUSION ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS IN 3 OR MORE LEVELS. USAGE:THE SPF HAS ONLY BEEN STUDIED AS AN ADJUNCT FOR LUMBAR SPINAL SURGERY." REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

D

Patient 1

RECEIVED THE FACILITY MEDWATCH REPORT WHICH STATES "THE PATIENT HAD A BONE GRAFT STIMULATOR IMPLANTED APPROXIMATELY ONE YEAR AGO. THE PHYSICIAN REQUESTED TO REMOVE THE STIMULATOR AS IT WAS NOT EFFECTIVELY PROGRESSING GROWTH OF THE BONE. THIS STIMULATOR WAS NOT REPLACED AT THIS TIME. NO KNOWN INJURY OCCURRED TO THE PATIENT."