MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-25 for OSSIX PLUS OXP3040 manufactured by Datum Dental Ltd..
[115061361]
A dentist reported that two ossix plus membranes appeared smaller than specified on the labelling. According to the dentist, 1st item measured 29 x 34 mm and 2nd item measured 29 x 35 mm, while specified as 30 x 40 mm. The measurements were taken on dry, prior to hydration, membranes. Two hufriedy unc 15 periodontal probes were used to measure the membranes. The dentist did not use these two membranes and used a third membrane instead. The patient anesthesia time was extended. The product's ifu instructs that ossix plus should be immersed for 30 seconds in sterile saline, to allow for its expansion to its final dimensions (15x25 mm, 25x30 mm, 30x40 mm).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010626093-2018-00003 |
| MDR Report Key | 7721283 |
| Date Received | 2018-07-25 |
| Date of Report | 2018-07-25 |
| Date of Event | 2018-07-06 |
| Date Mfgr Received | 2018-07-07 |
| Date Added to Maude | 2018-07-25 |
| 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 | DR. ARIE GOLDLUST |
| Manufacturer Street | 1 BAT SHEVA ST., POBOX 6170 |
| Manufacturer City | LOD, 7116003 |
| Manufacturer Country | IS |
| Manufacturer Postal | 7116003 |
| Manufacturer G1 | DATUM DENTAL LTD. |
| Manufacturer Street | 1 BAT SHEVA ST., POBOX 6170 |
| Manufacturer City | LOD, 7116003 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 7116003 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OSSIX PLUS |
| Generic Name | RESORBABLE COLLAGEN MEMBRANE |
| Product Code | NPL |
| Date Received | 2018-07-25 |
| Returned To Mfg | 2018-07-25 |
| Model Number | OXP3040 |
| Catalog Number | OXP3040 |
| Lot Number | OP33000044 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATUM DENTAL LTD. |
| Manufacturer Address | 1 BAT SHEVA ST., POBOX 6170 LOD, 7116003 IS 7116003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-25 |