MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-08 for POWERFLEX(TM) PECTORAL IMPLANT TEXTURED (NOVAK STYLE 2) N/A BNPI2-T-1R manufactured by Implantech Associates, Inc..
[141260116]
Methods: included testing of actual/suspected device and review of production records. Results: incorrect labeling. Conclusion: cause traced to manufacturing and quality control deficiency. Summary: investigation involved physical evaluation of the device associated with report. Though device had been separated from original packaging, evidence indirectly supported that device labeled as right side implant had logo imprint and dimensions that correspond to the left side device. The only other product manufactured on the same lot was evaluated and conformed to logo imprint and dimensions of a right side device. Review of device history records and lot distribution records has not identified any evidence to support that there was a product mix-up which involved any other products. If valid, the scope of this issue is currently limited to the one device associated with this report. The results are recorded as incorrect labeling as evidence suggests a left side device was labeled as a right side device. Implantech attributes cause to a manufacturing error, with a deficiency in the quality control processes as a secondary cause.
Patient Sequence No: 1, Text Type: N, H10
[141260137]
The patient was scheduled for bilateral placement of pectoral implant. The patient had already been placed under anesthesia, and pockets had been created for the implants. Complainant reported that device labeled as a bnpi2-t-1r was actually a bnpi2-t-1r, therefore they had 2 left side implant. The complainant attempted to use an available back-up device which was a different catalog item, however the difference in dimensions led complainant to decide back-up was not suitable. Complainant terminated the surgery without successful implantation of devices on either right or left side. Complainant reported that patient had successful bilateral implant surgery 12 days after initial surgery attempt. (note: implantech selected "other serious" rather than "required intervention... " because implantation of these devices is elective so 2nd surgery to implant devices was not deemed to be required. Nevertheless, the patient having to undergo 2 surgeries to have devices implanted rather than one was deemed by implantech to be an important medical event that qualified as "other serious". ).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028924-2019-00004 |
| MDR Report Key | 8493235 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-08 |
| Date of Report | 2019-04-08 |
| Date of Event | 2019-03-21 |
| Date Mfgr Received | 2019-03-21 |
| Device Manufacturer Date | 2018-05-10 |
| Date Added to Maude | 2019-04-08 |
| 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. CRAIG ARTHUR |
| Manufacturer Street | 6025 NICOLLE STREET, SUITE B |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal | 93003 |
| Manufacturer Phone | 8053399415 |
| Manufacturer G1 | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Street | 6025 NICOLLE STREET, SUITE B |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93003 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWERFLEX(TM) PECTORAL IMPLANT TEXTURED (NOVAK STYLE 2) |
| Generic Name | CONTOURED CARVING BLOCK IMPLANT |
| Product Code | MIC |
| Date Received | 2019-04-08 |
| Returned To Mfg | 2019-03-29 |
| Model Number | N/A |
| Catalog Number | BNPI2-T-1R |
| Lot Number | 877113 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Address | 6025 NICOLLE STREET, SUITE B VENTURA CA 93003 US 93003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-08 |