MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-06-12 for XCM BIOLOGIC TISSUE MATRIX 30010-30 manufactured by Dsm Biomedical.
[110804893]
A review of the d6860 batch record and it's associated intermediate manufacturing processes (pn 6445-30 ln d4559, pn 6199-03 ln d5851) confirmed there were no discrepancies associated with the product that could have impacted product performance. Additionally, for this product, there is no information in the ifu for use on patients undergoing radiation therapy. Upon review of the risk assessment and current controls in place, it was determined that the controls referenced in the risk analysis remain acceptable and applicable at this time. With a dhf review and risk assessment review being completed, all controls were correctly implemented and there were no discrepancies during manufacturing and no assignable root cause can be determined at this time.
Patient Sequence No: 1, Text Type: N, H10
[110804894]
It was reported that some postoperative complications with the xcm biologic tissue matrix were recorded after implantation of the xcm sheet together with the matrixrib plating system after chondrosarcoma tumor removal in (b)(6) 2017. Patient received radiation therapy to the surgical site for six weeks during (b)(6), during which the patient had a large amount of discharge. Patient had procedures for drainage of a recurrent pleural effusion in both (b)(6) and (b)(6) 2017. The wound was reopened in (b)(6) 2017 and it was observed that the xcm appeared to be dissolving. The xcm was removed and subsequently no further drainage was observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2018-00004 |
| MDR Report Key | 7593151 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-06-12 |
| Date of Report | 2018-06-11 |
| Date of Event | 2017-11-28 |
| Date Mfgr Received | 2018-05-15 |
| Date Added to Maude | 2018-06-12 |
| 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 | XCM BIOLOGIC TISSUE MATRIX |
| Generic Name | MESH, SURGICAL, COLLAGEN, LARGE ABDOMINAL WALL DEFECTS |
| Product Code | OXK |
| Date Received | 2018-06-12 |
| Model Number | 30010-30 |
| Lot Number | KND6860 |
| Device Availability | N |
| 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 | 2018-06-12 |