MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-21 for STRAUMANN MEMBRANEFLEX manufactured by Collagen Matrix, Inc..
[80921042]
Collagen matrix has made multiple unsuccessful attempts to obtain additional product information (i. E. Lot number, expiration date, udi). Due to insufficient feedback a thorough assessment could not be completed.
Patient Sequence No: 1, Text Type: N, H10
[80921043]
Clinician reported that the straumann membraneflex product resorbed within 2 weeks of being implanted. Typical resorption time for this membrane is 12-16 weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249852-2017-00005 |
| MDR Report Key | 6734633 |
| Date Received | 2017-07-21 |
| Date of Report | 2017-02-21 |
| Date Mfgr Received | 2016-08-01 |
| Date Added to Maude | 2017-07-21 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. GLORIA ZUCLICH |
| Manufacturer Street | 15 THORNTON ROAD |
| Manufacturer City | OAKLAND NJ 07436 |
| Manufacturer Country | US |
| Manufacturer Postal | 07436 |
| Manufacturer Phone | 2014051477 |
| Manufacturer G1 | COLLAGEN MATRIX, INC. |
| Manufacturer Street | 15 THORNTON ROAD |
| Manufacturer City | OAKLAND NJ 07436 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STRAUMANN MEMBRANEFLEX |
| Generic Name | COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP |
| Product Code | NPL |
| Date Received | 2017-07-21 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLLAGEN MATRIX, INC. |
| Manufacturer Address | 15 THORNTON ROAD OAKLAND NJ 07436 US 07436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-21 |