FDA.reportPublic FDA data

MAUDE MDR 4417714

MDR report key
4417714
Report number
3006396387-2015-00001
Event key
0
Event type
3
Date of event
2014-12-11
Date received
2015-01-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ROBERT FOUNDS
Address
3047 ORCHARD PARKWAY SAN JOSE CA 95134 US
Phone
408-408-4083
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VERTECOR MIDLLINE OSTEOTOME 3.0OSTEOTOMEDFINE INC.GFI33533353141124A02Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-01-090

Event Narratives#

D

Patient 1

THE PT HAD PREVIOUSLY UNDERGONE RADIATION THERAPY SUGGESTING THAT THE PT COULD HAVE HAD SCLEROTIC DENSE BONE, PREDISPOSING THE MIDLINE OSTEOTOME TO BECOMING EMBEDDED IN THE PT'S SACRUM. THE SIGNIFICANT SCLEROTIC NATURE OF THE BONE WAS FURTHER CONFIRMED WHEN THE PHYSICIAN WAS REQUIRED TO USE A MALLET TO DRIVE THE MLO INTO POSITION. UPON NUMEROUS ATTEMPTS TO WITHDRAW THE MLO FROM THE WORKING CANNULA, THE MLO WAS REMOVED IN CONJUNCTION WITH THE WORKING CANNULA RESULTING IN A PORTION OF THE DISTAL END OF THE INNER AND MIDDLE TUBES AS WELL AS THE ENTIRE LENGTH OF THE OUTER TUBE REMAINING LODGED IN THE PT. REMOVAL OF ALL BUT THE PORTION EMBEDDED IN THE SACRUM ITSELF WAS ACHIEVED WHEN THE DISTAL END OF THE OUTER TUBE FRACTURED UPON APPLYING TRACTION WITH A LARGE FORCEP TO THAT PORTION EXPOSED THROUGH THE SKIN. NO FURTHER SURGICAL INCISION WAS REQUIRED AND NO COMPONENT OF THE DEVICE REMAINED IN SOFT TISSUE. THE SACRUM WAS THEN AUGMENTED WITH PMMA CEMENT IMMOBILIZING THAT PORTION OF THE MLO MINIMIZING RISK ASSOCIATED WITH THE PORTION OF THE DEVICE REMAINING IN THE PT. THE PHYSICIAN CONFIRMED NO ADD'L INCISION WAS REQUIRED TO REMOVE THE EXTRAOSSEOUS PORTION OF THE MLO INITIALLY STUCK IN THE PT. THE PT WAS DOING WELL APPROX ONE WEEK POST-PROCEDURE. THE PROCEDURE RESULTED IN REDUCTION IN THE PT'S PAIN AND THERE WERE NO UNTOWARD EFFECTS TO THE DISTAL TIP OF THE MLO IMPLANTED IN THE PT. THE MLO APPEARS TO HAVE BEEN USED IN SCLEROTIC DENSE BONE. THE PRODUCT IFU CONTAINS A WARNING AGAINST USE OF THE MLO IN DENSE SCLEROTIC BONE. AFTER SPEAKING WITH PHYSICIAN, IT IS CLEAR THAT PT HARM WAS NOT ALLEGED, AND IS UNLIKELY BASED ON THE FACT THAT NO SOFT TISSUE INJURY OCCURRED. NO ADD'L SURGICAL INTERVENTION WAS REQUIRED IN THE RETRIEVAL OF THE LODGED DEVICE, THAT PORTION OF THE DEVICE THAT WAS UNABLE TO BE REMOVED WAS COMPLETELY EMBEDDED WITHIN THE CONFINES OF THE VERTEBRA AS WELL AS INTERDIGITATED WITH PMMA BONE CEMENT DURING THE AUGMENTATION PROCEDURE AND IS MANUFACTURED OF MEDICAL GRADE 316 STAINLESS STEEL, A MATERIAL COMMONLY USED IN ORTHOPEDIC IMPLANTS WITH GOOD BIOCOMPATIBILITY PROFILE.

N

Patient 1

DHR REVIEW: STABILIT FIRST FRACTURE KIT, SHORT BLISTER PACK, LOT @ 141124A02 (QTY (B)(4)), PN 3353; FIRST FRACTURE KIT, BLISTER PACK STERILE, SHORT DEVICES, LOT # M208406, PN 3352 (MIDLINE SUB-ASSEMBLY SHORT, PN39-03969-002-50, LOT # M208371 AND M208293); QPI 2803, END ITEM AUDIT TESTING, FRM2857, (B)(4) QTY ACCEPTED. NO ANOMALY WAS REVEALED THAT WAS IN RELATION TO THE COMPLAINT (B)(4). EVAL OF DEVICE: A REVIEW OF THE MATERIAL SPECIFICATIONS (B)(4), THE MATERIAL OF THE VERTECOR MIDLINE OSTEOTOME 3.0, PN 3765 CONFIRMED THAT THE TIP OF THE DEVICE IS MADE FROM MEDICAL GRADE 316 STAINLESS STEEL. SIMILAR TO PEDICLE SCREWS, COMMONLY USED AS PERMANENT IMPLANTS IN FUSION SPINE SURGERY. REVIEW OF IFU 1311, REV. AL, WARNING NOTE #7 STATES: DO NOT USE THIS PRODUCT IN DENSE BONE INCLUDING TRAUMATIC FRACTURES, DEVICE DAMAGE RESULTING IN PT INJURY MAY OCCUR.

N

Patient 1

ONE UNIT WAS RETURNED FOR EVALUATION. THE DEVICE WAS EXAMINED VISUALLY. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE IS ATTRIBUTED TO EXCESSIVE FORCE APPLIED DURING USE. A REVIEW OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND FOR THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO EXCEPTION DOCUMENTS WERE FOUND.