MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-02-13 for APTIS DRUJ DRUJ-LP20 manufactured by Aptis Medical.
[99936917]
Detailed instructions including visual references are provided to both surgeons and representatives prior to surgery. The section in the technique guide labeled as "radial plate trial positioning" pages 11-13 details proper positioning. Based on the evaluation of the x-ray, these guidelines were not followed. Numerous attempts to obtain patient's weight have been unsuccessful so we have put in 000 pounds in order to submit within the required timeframe.
Patient Sequence No: 1, Text Type: N, H10
[99936918]
During the initial implantation of the device the plate was placed angulated, approximately 40 degrees from the optimum position described in our technique. The improper position of the plate created an angle with the ulnar stem that was beyond its intended range of motion. The excessive angle allowed the metal of the peg to contact the metal of the distal radial plate. During use this created excessive forces leading to fracture of the distal peg approximately four months after implantation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004521401-2018-00001 |
| MDR Report Key | 7267384 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-02-13 |
| Date of Report | 2018-01-14 |
| Date of Event | 2017-09-25 |
| Date Mfgr Received | 2018-01-14 |
| Device Manufacturer Date | 2016-07-20 |
| Date Added to Maude | 2018-02-13 |
| 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 | MRS BARBARA CHESHER |
| Manufacturer Street | 3602 GLENVIEW AVE |
| Manufacturer City | GLENVIEW KY 40025 |
| Manufacturer Country | US |
| Manufacturer Postal | 40025 |
| Manufacturer Phone | 5024258584 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APTIS DRUJ |
| Generic Name | DISTAL RADIO-ULNAR JOINT IMPLANT |
| Product Code | KXE |
| Date Received | 2018-02-13 |
| Model Number | DRUJ-LP20 |
| Catalog Number | DRUJ-LP20 |
| Lot Number | K19353 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APTIS MEDICAL |
| Manufacturer Address | 3602 GLENVIEW AVE GLENVIEW KY 40025 US 40025 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-13 |