MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-01-22 for XCM BIOLOGIC TISSUE MATRIX 30012-25 manufactured by Dsm Biomedical.
[97874348]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[97874349]
It was reported that the xcm biologic tissue matrix was used to reconstruct the anterolateral thoracic wall and was covered with a myocutaneous latissimus dorsi muscle flap. The thoracic wall resection was due to chronic osteomyelitis of the thoracic wall after radiogenic damage. There was a local infection with a need for re-operation. During the revision, after detachment of the vital and well-perfused muscle flap, the membrane was completely decomposed and there was a direct view of the lungs and other intra-thoracic organs. For discussion is whether the implant is not explicitly declared as contraindicated in case of possible infection. The implant was used because it is a biologic and should be considered less susceptible to infection. This complaint involves 1 device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530154-2018-00001 |
| MDR Report Key | 7209109 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-22 |
| Date of Report | 2018-01-17 |
| Date of Event | 2016-11-30 |
| Date Mfgr Received | 2018-01-05 |
| Device Manufacturer Date | 2016-06-24 |
| Date Added to Maude | 2018-01-22 |
| 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 |
| Manufacturer Phone | 4847132165 |
| 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 | 2018-01-22 |
| Model Number | 30012-25 |
| Lot Number | KND6413 |
| Device Expiration Date | 2019-06-28 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-01-22 |