FDA.reportPublic FDA data

MAUDE MDR 6985338

MDR report key
6985338
Report number
3004774118-2017-00168
Event key
0
Event type
3
Date of event
2017-09-28
Date received
2017-10-27
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
MS. SANDRA GILBERT
Address
600 HOPE PARKWAY SE LEESBURG VA 20175 US
Phone
571-571-5719
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NILE ALTERNATIVE FIXATION SPINAL SYSTEMBONE FIXATION CERCLAGEK2M INC.OWI5416-F04730-SGEEKP-22975Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-10-2701. R

Event Narratives#

N

Patient 1

A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. A REVIEW OF ALL APPLICABLE MATERIAL, INSPECTION, MANUFACTURING, AND DISTRIBUTION RECORDS ACCORDING TO THE DESCRIPTION OF THE PRODUCT(S) USED WAS CONDUCTED. ALL RECORDS REVEALED THAT ALL PRODUCT(S) LOTS WERE MANUFACTURED WITHIN SPECIFICATIONS AND DISTRIBUTED IN ACCORDANCE WITH ALL OPERATING PROCEDURES. GIVEN THE TYPE OF CORRECTION AND THE APPARENT POOR BONE QUALITY OF THE PATIENT, IT IS LIKELY THAT THE T3 LAMINA FRACTURED DUE TO THE BIOMECHANICAL LOADING BEING APPLIED AT THAT LEVEL BY THE CONSTRUCT. ONCE THE BONE FRACTURED, THE COMPRESSION BEING APPLIED TO THE LAMINAR HOOKS WAS RELEASED AND THE NON-IDEAL CONTACT BETWEEN THE SET SCREWS AND THE ROD ALLOWED THE LAMINAR HOOKS TO MOVE RELATIVE TO THE ROD.

D

Patient 1

ON 09.29.2017 IT WAS REPORTED TO K2M, INC. THAT A REVISION SURGERY TOOK PLACE IN WHICH BROKEN LAMINAR HOOKS, BANDS AND SET SCREW WERE REMOVED. REVISION SURGERY TOOK PLACE ON (B)(6) 2017. RELATED TO 3004774118-2017-00158, 3004774118-2017-00169 AND 3004774118-2017-00170.