MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-20 for INTEGRA BOVINE PERICARDIUM DURAL GRAFT BP10812 manufactured by Tutogen Medical Gmbh.
[68485617]
Pt had craniotomy on (b)(6) 2016, with dural implanted and returned to operating room on (b)(6) 2017 for intracranial infection. Operation: left craniectomy, debridement of subdural empyema. Findings: purulent material in the subdural space. Bone flap, fixation clips and dural graft removed, cultures taken. On (b)(6) 2017, culture results:. Anaerobic culture duragen patch from tissue/head. Positive propionibacterium acnes anaerobic culture left bone flap from bone/head. Positive propionibacterium acnes anaerobic culture from subdural fluid 1 from tissue/head. Positive head: positive propionibacterium acnes tissue culture and smear and anaerobic culture from subdural fluid 2 from tissue/head. Positive propionibacterium acnes tissue. Culture and smear from duragen patch from graft/head. Positive staphylococcus coagulase negative bone culture and smear from left bone/head. Positive staphylococcus capitis tissue culture and smear from subdural fluid 1 tissue/head. Positive propionibacterium granulosum. On (b)(6) 2016, operation - left frontocentroparietal craniotomy excision of meningioma. Implanted dural graft and fixation clips. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068140 |
| MDR Report Key | 6360798 |
| Date Received | 2017-02-20 |
| Date of Report | 2017-02-20 |
| Date of Event | 2017-01-25 |
| Date Added to Maude | 2017-02-27 |
| 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 |
| 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 | 0 |
| Brand Name | INTEGRA BOVINE PERICARDIUM DURAL GRAFT |
| Generic Name | DURAL GRAFT |
| Product Code | GXQ |
| Date Received | 2017-02-20 |
| Catalog Number | BP10812 |
| Lot Number | 000000013380389 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TUTOGEN MEDICAL GMBH |
| Manufacturer Address | NEUNKIRCHEN A. BR. 91077DE 91077 DE |
| Brand Name | TITANIUM CLAMP CRANIOFIX 2 |
| Generic Name | TITANIUM CLAMP |
| Product Code | GDJ |
| Date Received | 2017-02-20 |
| Lot Number | 52246501 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP/B. BRAUN |
| Brand Name | TITANIUM CLAMP CRANIOFIX 2 |
| Generic Name | TITANIUM CLAMP |
| Product Code | GDJ |
| Date Received | 2017-02-20 |
| Lot Number | 52187756 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP/B. BRAUN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2017-02-20 |