MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-16 for CYTOPLAST REGENTEX TITANIUM 250 TI150XLK-2 manufactured by Osteogenics Biomedical, Inc..
[97475228]
At this time, complete information is not available in spite of efforts to obtain further information. Contact was made with the dentist; however, the response time has been slow and the information received has been incomplete and unclear. The information given in this report is all the information that has been obtained at this time. This device was sold and used in (b)(6). We are submitting this report to be conservative and in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[97475229]
A spontaneous report pertaining to cytoplast titanium-reinforced ptfe membrane was received from a dentist in (b)(6) on (b)(6) 2017. The dentist stated that he use a titanium-reinforced membrane in a bone grafting procedure and reentered the site after 6 months. The dentist stated that the soft tissue looked nice with no dehiscences before reopening the site. When the flap was opened there was no bone and there seemed to be an infection. The doctor also stated that the membrane itself seemed to disintegrate. This has happened on four cases.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1650372-2018-00001 |
| MDR Report Key | 7197990 |
| Date Received | 2018-01-16 |
| Date of Report | 2018-04-05 |
| Date Mfgr Received | 2017-12-18 |
| Date Added to Maude | 2018-01-16 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. SHANE SHUTTLESWORTH |
| Manufacturer Street | 4620 71ST. ST. BLDG. 78 |
| Manufacturer City | LUBBOCK TX 79424 |
| Manufacturer Country | US |
| Manufacturer Postal | 79424 |
| Manufacturer G1 | OSTEOGENICS BIOMEDICAL, INC. |
| Manufacturer Street | 4620 71ST. ST. BLDG. 78 |
| Manufacturer City | LUBBOCK TX 79424 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 79424 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CYTOPLAST REGENTEX TITANIUM 250 |
| Generic Name | NON-ABSORBABLE BARRIER MEMBRANE |
| Product Code | LYC |
| Date Received | 2018-01-16 |
| Model Number | TI150XLK-2 |
| Lot Number | A117044 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTEOGENICS BIOMEDICAL, INC. |
| Manufacturer Address | 4620 71ST. ST. BLDG. 78 LUBBOCK TX 79424 US 79424 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-16 |