MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-13 for BIO-GIDE / BIO-OSS COLLAGEN MEMBRANE 20151 manufactured by Geistlich Pharma Ag.
[180100395]
On (b)(6) 2017, i underwent double jaw surgery. During the surgery, the surgeon severed my inferior alveolar nerve and repaired it using a bio-gide and / or bio-oss collagen membrane. For a month i continued to have severe impaired and altered sensation and at 1 year post bio-gide repair, a nerve graft repair was attempted but the nerve was found to have deteriorated into fibrotic fatty tissue and was dying and in disrepair. Mri neurography revealed the nerve was non continuous and severely damaged; 2 different microneurosurgeons had extreme difficulty finding the nerve for grafting. The operative report has listed a bio-oss membrane implanted; however, the surgeon described using a bio-gide collagen membrane that is not listed on the operative implant record. I have not seen evidence that either bio-gide nor bio-oss collagen products are approved by the fda for nerve repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093009 |
| MDR Report Key | 9711669 |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-05 |
| Date of Event | 2017-12-06 |
| Date Added to Maude | 2020-02-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO-GIDE / BIO-OSS COLLAGEN MEMBRANE |
| Generic Name | BARRIER, ANIMAL SOURCE, INTRAORAL |
| Product Code | NPL |
| Date Received | 2020-02-13 |
| Model Number | 20151 |
| Lot Number | 81600973 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GEISTLICH PHARMA AG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2020-02-13 |