MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-13 for 3D ACCUSCAN IMPLANT 3D-ACCUSCAN-672-1 manufactured by Implantech Associates Inc..
[6051143]
Complainant reported that patient had a mandibular implant explanted approximately 3 months post-operatively due to infection. No culture was taken, so no organism has been identified. Patient was first given an antibiotic (penzeek? P. O. ) about 1 week post-operatively and later presented with right mandibular area tender to the touch, but with no edema or erythema. Approximately 12 weeks post-operatively, patient experienced swelling, but no fever, and physician explained device about 1 week later.
Patient Sequence No: 1, Text Type: D, B5
[14032740]
Method: actual device not evaluated, sterilization review, manufacturing review (reviewed device history records, sterilization records, environmental monitoring records and product labeling. Results: anticipated or known (product labeling addresses the possibility of infection. Conclusions: unable to confirm complaint. (investigation found no assignable cause for the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2015-00003 |
| MDR Report Key | 4919693 |
| Report Source | 05 |
| Date Received | 2015-07-13 |
| Date of Report | 2015-07-13 |
| Date of Event | 2015-06-25 |
| Date Mfgr Received | 2015-07-01 |
| Device Manufacturer Date | 2015-03-01 |
| Date Added to Maude | 2015-07-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CRAIG ARTHUR |
| Manufacturer Street | 6025 NICOLLE ST. |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal | 93003 |
| Manufacturer Phone | 8053399415 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3D ACCUSCAN IMPLANT |
| Generic Name | SILICONE FACIAL IMPLANT |
| Product Code | MIB |
| Date Received | 2015-07-13 |
| Model Number | NA |
| Catalog Number | 3D-ACCUSCAN-672-1 |
| Lot Number | 859430 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPLANTECH ASSOCIATES INC. |
| Manufacturer Address | VENTURA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-13 |