MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-10-28 for CONTOUFLEX (TM) TEARDROP GLUTEAL IMPLANT N/A CCB6-2 manufactured by Implantech Associates, Inc..
[58716904]
Patient code deemed not applicable as patient has not yet had intervention. This event is being reported as a malfunction. Device code is break per complainant's report, pending further analysis should be device be explanted and returned. Method codes reflect that device has not been returned to implantech at this time, however a review of the device history record has found no assignable cause for the reported event. Results code reflects that no results are available since device itself has not yet been evaluated. Conclusion codes reflects that implantech has not yet been able to confirm the complaint.
Patient Sequence No: 1, Text Type: N, H10
[58717085]
Complainant reported that patient contacted their office to report that her gluteal implant had split in two. The patient was implanted bilaterally, and the reported problem is associated with right side device. Report occurred more than 6 years post-operatively. Surgery to replace the right side device is scheduled for (b)(6) 2016. The event is not being reported as an adverse event because there has not yet been intervention, and the patient has not yet been seen by the reporting physician. Implantech is reporting this as a malfunction because the possibility of reportable serious injury occuring as a result of a recurrence of this type of event is not remote.
Patient Sequence No: 1, Text Type: D, B5
[65248692]
Additional narrative: this report is being updated to reflect the explant date of the device: (b)(6) 2016. The explant of the device has caused implantech to report this event as a serious injury in addition to a malfunction. The device was returned for evaluation. The results of the evaluation are in the evaluation summary below. Evaluation summary: the device was returned in two pieces and was split across the width of the device. Approximately half of the edge of the split was rough or jagged and the remainder had a relatively smooth edge. The two pieces meshed well, and there was no noticeable material missing. Implantech could neither confirm or rule out iatrogenic damage as a contributing factor. Implantech was unable to determine a probable cause for this event. Method codes were updated to reflect the actual device was evaluated. Results code selected was fracture problem as most appropriate code available. Conclusion code reflects known inherent risk of procedure as labeling indicates the possibility of explant surgery taking place at any time after implantation should be discussed with the patient and that these devices should not be considered lifetime implants and explant surgery may be indicated at any time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028924-2016-00002 |
| MDR Report Key | 6063884 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-10-28 |
| Date of Report | 2016-01-13 |
| Date of Event | 2016-09-08 |
| Date Mfgr Received | 2016-09-29 |
| Device Manufacturer Date | 2010-05-13 |
| Date Added to Maude | 2016-10-28 |
| 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 |
| Manufacturer City | VENTURA CA 93003 |
| Manufacturer Country | US |
| Manufacturer Postal | 93003 |
| Manufacturer Phone | 8033399415 |
| Manufacturer G1 | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Street | 6025 NICOLLE STREET |
| 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 | CONTOUFLEX (TM) TEARDROP GLUTEAL IMPLANT |
| Generic Name | GLUTEAL IMPLANT |
| Product Code | MIB |
| Date Received | 2016-10-28 |
| Returned To Mfg | 2016-12-21 |
| Model Number | N/A |
| Catalog Number | CCB6-2 |
| Lot Number | 835405 |
| Device Expiration Date | 2015-05-01 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPLANTECH ASSOCIATES, INC. |
| Manufacturer Address | 6025 NICOLLE STREET VENTURA CA 93003 US 93003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-10-28 |