VSP SYSTEM VSPO N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-07-07 for VSP SYSTEM VSPO N/A manufactured by 3d Systems, Inc..

Event Text Entries

[49022327] Not returned.
Patient Sequence No: 1, Text Type: N, H10


[49022328] The patient specific intermediate surgical splints provided for a segmental lefort i, bsso, and genioplasty surgery were for the incorrect patient. The patient was under anesthesia prior to surgery when the error was recognized by the operating physician. Correct intermediate surgical splints were manufactured the same day and sent to the operating physician. The new intermediate splints were used in a successful follow-up surgery the following day ((b)(6) 2016) the sla 5000 arthroview build (3d printing) on (b)(6) 2016 failed entirely. The build contained vspo intermediate surgical splints, most of which were due to ship out on (b)(6) 2016. Due to this, three separate arthroview re-builds containing splints from the sla 5000 (b)(6) 2016 build were started on the morning of (b)(6) 2016. When the splints from the original ar5000 (b)(6) 2016 build platform were separated into three machines to be rebuilt, the intermediate surgical splints for wo#(b)(4) were mistakenly not loaded into any build. The device history records (travelers) on this day were paired with their corresponding accuview final surgical splints (that were built successfully on (b)(6) 2016), and those were inspected prior to the rebuilt arthroview splints from the three morning builds finishing production. When the rebuilt arthroview splints were ready for final inspection in the afternoon, they were paired with their associated case based off reading the work order # on the part itself and placing them into the bin containing the rest of the parts/documentation for that case. During the sorting process, intermediate surgical splints for (b)(4) were placed with the parts and documentation for work order # (b)(4) (likely because of the similarities in work order numbers). The operating physician provides digital stone models using the charlotte method on his cases, thus parts do not have associated physical stone models. This allows only a visual inspection and verifying the part's thickness during the final inspection process, and fit checks cannot be conducted. (b)(4) final inspection personnel did not verify the part's labeling during the inspection of the intermediate surgical splints (the rest of the case had already been checked). During final inspection by quality personnel, the intermediate surgical splints' part labels were also not verified.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1724955-2016-00002
MDR Report Key5776957
Report SourceHEALTH PROFESSIONAL
Date Received2016-07-07
Date of Report2016-07-07
Date of Event2016-06-16
Date Mfgr Received2016-06-16
Device Manufacturer Date2016-06-08
Date Added to Maude2016-07-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. SCOTT BREWER
Manufacturer Street5381 SOUTH ALKIRE CIRCLE
Manufacturer CityLITTLETON CO 80127
Manufacturer CountryUS
Manufacturer Postal80127
Manufacturer Phone7206431001
Manufacturer G1HEALTHCARE
Manufacturer Street5381 SOUTH ALKIRE CIRCLE
Manufacturer CityLITTLETON CO 80127
Manufacturer CountryUS
Manufacturer Postal Code80127
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVSP SYSTEM
Generic NameBONE CUTTING INSTRUMENT AND ACCESSORIES
Product CodeDZJ
Date Received2016-07-07
Model NumberVSPO
Catalog NumberN/A
Lot Number71766
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
Manufacturer3D SYSTEMS, INC.
Manufacturer Address5381 SOUTH ALKIRE CIRCLE LITTLETON CO 80127 US 80127


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2016-07-07

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