MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-03-29 for XYMPHONY DENTAL MEMBRANE 30071-01 manufactured by Dsm Biomedical.
[103815340]
During the investigation of this complaint, as there was no product return, the complaint could not be formally duplicated, only verified by feedback provided by salvin. All applicable device history records, sterilization records, and risk assessments were reviewed, and no discrepancies applicable to this complaint were noted. It has been determined that response exhibited in the patient cannot solely be attributed to the device, as the review of the device history record showed no discrepancies during the manufacturing of this lot. A request for additional information to better address the recorded response within the patient, has been made to salvin.
Patient Sequence No: 1, Text Type: N, H10
[103815341]
It was reported that a patient who is systemically healthy had bone deficiency at tooth # 20 and underwent a ridge preservation. During the procedure the following products were used: lifenet fdba, xymphony membrane and chromic gut sutures. The area deficient of bone was covered with the membrane and further covered by the patient's soft tissue. No procedural complications were reported. On day 2 post-procedure, the patient exhibited signs of an allergic response. On day 9 post-procedure, the site was opened, and the membrane was removed. The site was ulcerated on the lingual side and swollen on the buccal. Per the surgeon, the site was warm, red and streaky like an allergy. The fdba was left in place, and the sutures had already dissolved. It was reported that the patient reaction was 99% better following removal of the membrane.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2018-00003 |
| MDR Report Key | 7381337 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-03-29 |
| Date of Report | 2018-04-16 |
| Date Mfgr Received | 2018-03-01 |
| Date Added to Maude | 2018-03-29 |
| 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 | MRS. ALICE COUSENS |
| Manufacturer Street | 735 PENNSYLVANIA DRIVE |
| Manufacturer City | EXTON PA 19341 |
| Manufacturer Country | US |
| Manufacturer Postal | 19341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XYMPHONY DENTAL MEMBRANE |
| Generic Name | BARRIER, ANIMAL SOURCE, INTRAORAL |
| Product Code | NPL |
| Date Received | 2018-03-29 |
| Model Number | 30071-01 |
| Lot Number | E0234 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DSM BIOMEDICAL |
| Manufacturer Address | 735 PENNSYLVANIA DRIVE EXTON PA 19341 US 19341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-29 |