MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-01-12 for OSSIX PLUS manufactured by Datum Dental Ltd..
[64715167]
The device was not explanted.
Patient Sequence No: 1, Text Type: N, H10
[64715168]
It was reported that a patient experienced a rash on torso, legs, arms and scalp, which lasted for over 20 days after procedure. Reportedly, the patient was treated and underwent a guided bone regeneration procedure with biooss graft (from another manufacturer) and ossix plus. Patient had an extraction and was also placed on systemic clindamycin. The rash started after the clindamycin (the first antibiotic taken). On (b)(6) 2016, approximately 3 weeks post procedure, the patient returned for a follow-up visit with excellent healing in the surgical area, but a systemic rash, which was getting worse in the torso area. On (b)(6) 2016 the physician placed arestin 1mg minocycline microspheres. The patient saw a dermatologist for the rash and was placed on prednisone. A biopsy was done and ruled out pemphigus. The patient also developed colitis and is taking metronidazole. Patient is taking prednisone as well and has no other allergies. Patient is going to a medical center to complete medical evaluation and complete blood workup including evaluation of stevens-johnson syndrome.
Patient Sequence No: 1, Text Type: D, B5
[67466239]
The device was not explanted.
Patient Sequence No: 1, Text Type: N, H10
[67466240]
Additional information was received. Upon follow-up with the physician for patient's medical condition, the physician stated that the patient had been seen by several specialists at a medical center and the specialists believed the rash was unrelated to the dental surgery. No other information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010626093-2017-00001 |
| MDR Report Key | 6247504 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-01-12 |
| Date of Report | 2017-02-13 |
| Date of Event | 2016-10-17 |
| Date Mfgr Received | 2017-02-09 |
| Date Added to Maude | 2017-01-12 |
| 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 | DR. ARIE GOLDLUST |
| Manufacturer Street | 1 BAT SHEVA ST. |
| Manufacturer City | LOD, 7120101 |
| Manufacturer Country | IS |
| Manufacturer Postal | 7120101 |
| Manufacturer Phone | 86705400 |
| Manufacturer G1 | DATUM DENTAL LTD. |
| Manufacturer Street | 1 BAT SHEVA ST. |
| Manufacturer City | LOD, 7120101 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 7120101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSSIX PLUS |
| Generic Name | RESORBABLE COLLAGEN MEMBRANE |
| Product Code | NPL |
| Date Received | 2017-01-12 |
| Model Number | OSSIX PLUS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATUM DENTAL LTD. |
| Manufacturer Address | 1, BAT SHEVA ST. LOD, 7120101 IS 7120101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-12 |