FDA.reportPublic FDA data

MAUDE MDR 5912067

MDR report key
5912067
Report number
1724955-2016-00003
Event key
0
Event type
3
Date of event
2016-07-27
Date received
2016-08-29
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
MR. SCOTT BREWER
Address
5381 SOUTH ALKIRE CIRCLE LITTLETON CO 80127 US
Phone
720-720-7206
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VSP SYSTEMVSP ORTHOGNATHICS3D SYSTEMSDZJVSPO74484N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-08-2901. O

Event Narratives#

N

Patient 1

DEVICE NOT RETURNED.

D

Patient 1

VSP PRODUCT PATIENT SPECIFIC DELIVERABLES FOR THE INCORRECT PATIENT WERE SHIPPED TO THE WRONG LOCATION AND WERE INCORRECTLY LABELED. DELIVERABLES FOR WORK ORDER (WO) # (B)(4) WERE SHIPPED TO THE INCORRECT LOCATION ON 07/27/2016. THE PARTS WERE SENT TO THE SHIPPING ADDRESS FOR WO# (B)(4). DELIVERABLES FOR WO# (B)(4) CONTAINED PART PACKAGE LABELS REFLECTING THE CASE INFORMATION FOR WO# (B)(4). THE VSPO CASE BUNDLE FOR WO# (B)(4) WAS INTENDED TO SHIP ON 07/27/2016, BUT WAS TO BE HELD BECAUSE THE BILLING DOCUMENTATION HAD NOT YET BEEN COMPLETED. THE NONCONFORMANCE WAS IDENTIFIED ON 07/28/2016 WHEN BILLING DOCUMENTATION WAS BEING CREATED FOR WO# (B)(4) AND THE INTERNAL PATIENT DATABASE ENTRY FOR THAT CASE ALREADY HAD A (B)(6) TRACKING NUMBER (THE TRACKING NUMBER STATED THE PACKAGE HAD BEEN DELIVERED). QUALITY PERSONNEL THEN DETERMINED DELIVERABLES FOR A DIFFERENT CASE (WO#(B)(4)) WAS SENT USING THE WO# (B)(4) SHIPPING LABEL BY LOOKING AT THE SHIPPING LABEL REFERENCE STICKERS PLACED INTO EVERY DEVICE HISTORY RECORD AFTER SHIPMENT FOR CASES THAT SENT 07/27/2016 (THESE STICKERS LIST THE TRACKING NUMBER FOR THAT SHIPPING LABEL). UPON IDENTIFICATION THAT DELIVERABLES FOR WO# (B)(4) WERE SENT TO THE INCORRECT LOCATION, THE RECIPIENT OF INCORRECT PARTS WAS IMMEDIATELY NOTIFIED BY QUALITY PERSONNEL AND AGREED TO DESTROY THE INCORRECT PARTS. THE CORRECT DELIVERABLES FOR WO# (B)(4) WERE SHIPPED TO THE MR. (B)(6) ON 07/28/2016 FOR USAGE IN SURGERY ON (B)(6) 2016. ALSO UPON IDENTIFICATION THAT DELIVERABLE FOR WO# (B)(4) WERE SENT TO THE INCORRECT LOCATION, THE INTENDED RECIPIENT OF PARTS FOR WO# (B)(4) WAS IMMEDIATELY NOTIFIED BY VSPO PERSONNEL. VSPO PERSONNEL COORDINATED A SATURDAY (07/30/2016) DELIVERY OF DUPLICATE PARTS TO THE SALES REPRESENTATIVE AS WELL AS A MONDAY (08/01/2016) DELIVERY OF DUPLICATE PARTS TO THE SURGEON (DR. (B)(6)) FOR SURGERY ON (B)(6) 2016. BOTH SET OF DUPLICATE PARTS WERE MANUFACTURED ON 07/29/2016 AND SHIPPED ON 07/29/2016. THERE WERE NO EFFECTS TO THE PATIENTS AND SURGERIES WERE PERFORMED AS PLANNED. HOWEVER, IF THE ISSUE HAD NOT BEEN IDENTIFIED PRIOR TO THE PARTS BEING RECEIVED BY THE OPERATING PHYSICIAN, THERE IS A POSSIBILITY THE INCORRECT PARTS COULD HAVE MADE IT TO SURGERY BEFORE BEING IDENTIFIED AS INCORRECT. THE ROOT CAUSE WAS DETERMINED TO BE A MIX UP OF BILLING DOCUMENTATION, CASE REPORTS, PRODUCT LABELS, AND SHIPPING LABELS FOR THE TWO MENTIONED WO NUMBERS. THE MIX UP WAS NOT CAUGHT AT FINAL QC INSPECTION OR IN SHIPPING. 3D SYSTEMS INITIATED A CORRECTIVE AND PREVENTIVE ACTION (CAPA) TO FURTHER ADDRESS THE ISSUE AND PREVENT REOCCURRENCE.