MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-02 for COPIOS EXTEND 0192Z manufactured by Collagen Matrix, Inc..
[88117870]
Device history record review and additional qc reserve sample testing confirms that the production lot met release criteria. There are no indications that the device would not function as designed.
Patient Sequence No: 1, Text Type: N, H10
[88117871]
The clinician reported that the membrane did not hold form and disintegrated 2 days following the implantation. No information was provided whether primary closure was achieved and the clinician did not report any adverse reactions or patient injury as a result of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249852-2017-00015 |
| MDR Report Key | 6908791 |
| Date Received | 2017-10-02 |
| Date of Report | 2017-09-27 |
| Date of Event | 2017-09-05 |
| Date Mfgr Received | 2017-09-05 |
| Device Manufacturer Date | 2017-02-08 |
| Date Added to Maude | 2017-10-02 |
| 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 | 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 | COPIOS EXTEND |
| Generic Name | COLLAGEN DENTAL MEMBRANE V |
| Product Code | NPL |
| Date Received | 2017-10-02 |
| Model Number | 0192Z |
| Lot Number | PDMU17A1 |
| Device Expiration Date | 2019-01-31 |
| Operator | PHYSICIAN |
| 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 | 2017-10-02 |