MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-10-25 for CYTOPLAST REGENTEX TITANIUM 250 TI150BL-2 manufactured by Osteogenics Iomedical, Inc..
[125099150]
Guided bone regeneration (gbr) procedures are highly technique sensitive, and dehiscence is a well-published complication. In one peer-reviewed published paper studying the clinical classification of complications in gbr procedures utilizing non-resorbable membranes, the authors state that "membrane exposure is generally considered the most common drawback of gbr procedures. " the authors went on to discuss that "nowadays, it can be assumed that membrane exposure is a 'predictable' complication. " further, there are recognized protocols and practices for classifying and dealing with membrane exposures. A review of the device history record revealed no abnormalities, and the device was sterilized correctly. This is the first complaint from this lot of 99 devices. This device was sold and used in germany. We are submitting this report to be conservative and in an abundance of caution. Fontana f, mashera e, rocchietta i, simion m. Clinical classification of complications in guided bone regeneration procedures by means of a nonresorbable membrane. International journal of periodontics and restorative dentistry 2011;31:265-273.
Patient Sequence No: 1, Text Type: N, H10
[125099151]
A guided bone regeneration procedure was performed on a patient along with simultaneous placing of a dental implant in position 46 (edentulous space)with non-optimal bone width. Autogenous bone was used and a ti150bl membrane was placed. The membrane was not trimmed, and was fixed with pins in the vestibular and lingual. The site was closed with two-layers of suture. Antibiotic therapy was given and there was post-operative swelling. 3 weeks later, the suture was removed and there was no irritation. 4 weeks later, there was a small lingual dehiscence with exudate secretion. Broad spectrum antibiotic therapy was given. 3 months later, the membrane was removed due to "perimandibular infiltrate (almost abscess)" and the membrane delaminated in the region of dehiscence. The implant stayed in-situ and the bone regeneration was successful despite the dehiscence and abscess.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1650372-2018-00002 |
| MDR Report Key | 8007678 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-10-25 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-07-20 |
| Date Mfgr Received | 2018-09-25 |
| Date Added to Maude | 2018-10-25 |
| 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 Phone | 8067961923 |
| Manufacturer G1 | OSTEOGENICS BIOMEDICAL, INC. |
| Manufacturer Street | 4620 71ST. ST. BLDG. 75 |
| 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 | 3 |
| Brand Name | CYTOPLAST REGENTEX TITANIUM 250 |
| Generic Name | NON-ABSORBABLE BARRIER MEMBRANE |
| Product Code | LYC |
| Date Received | 2018-10-25 |
| Model Number | TI150BL-2 |
| Lot Number | A087073 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTEOGENICS IOMEDICAL, INC. |
| Manufacturer Address | 4620 71ST ST. BLDG. 78 LUBBOCK TX 79424 US 79424 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-25 |