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..
[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
| Report Number | 1724955-2016-00002 |
| MDR Report Key | 5776957 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-07-07 |
| Date of Report | 2016-07-07 |
| Date of Event | 2016-06-16 |
| Date Mfgr Received | 2016-06-16 |
| Device Manufacturer Date | 2016-06-08 |
| Date Added to Maude | 2016-07-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. SCOTT BREWER |
| Manufacturer Street | 5381 SOUTH ALKIRE CIRCLE |
| Manufacturer City | LITTLETON CO 80127 |
| Manufacturer Country | US |
| Manufacturer Postal | 80127 |
| Manufacturer Phone | 7206431001 |
| Manufacturer G1 | HEALTHCARE |
| Manufacturer Street | 5381 SOUTH ALKIRE CIRCLE |
| Manufacturer City | LITTLETON CO 80127 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80127 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VSP SYSTEM |
| Generic Name | BONE CUTTING INSTRUMENT AND ACCESSORIES |
| Product Code | DZJ |
| Date Received | 2016-07-07 |
| Model Number | VSPO |
| Catalog Number | N/A |
| Lot Number | 71766 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3D SYSTEMS, INC. |
| Manufacturer Address | 5381 SOUTH ALKIRE CIRCLE LITTLETON CO 80127 US 80127 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-07-07 |