MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-11 for CERAFIX DURA SUBSTITUTE C1-4X5 manufactured by Acera Surgical, Inc.
[178735065]
On september 6th, 2018, acera first received feedback from (b)(6) regarding the product from lot 20147. The feedback described that the product used by dr. (b)(6) from (b)(6) hospital observed a cerebral spinal fluid leak post operation. The patient safety was confirmed. As a result of the received feedback, acera opened a complaint investigation. Acera reviewed the lot record and usage information for lot 20147 products. When products from lot 20147 were exhausted from acera, no other complaints were observed from this lot except for d02-14-c636 from (b)(6). Acera also collected more usage details from the doctor through (b)(6) and discovered that the product was used in an onlay application without tensionless sutures in a cerebellar tumor removal case. The cause of the product was narrowed down to a contra-indicated off-label use in a high-pressure area of the brain. When this event was initially investigated, it was determined to not be reportable because it occurred in (b)(6). But, after future learnings, it was determine that this decision was made in error, and the organization is now reporting this event that occurred in 2018.
Patient Sequence No: 1, Text Type: N, H10
[178735066]
During post-op review, it was noticed that the patient had a csf leak. The surgeon decided to operate to address and found that the device (cerafix) may have resorbed too quickly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012429393-2019-00002 |
| MDR Report Key | 9696344 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-11 |
| Date of Report | 2019-11-05 |
| Date of Event | 2018-09-04 |
| Date Mfgr Received | 2018-09-07 |
| Date Added to Maude | 2020-02-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOSHUA TUCKER |
| Manufacturer Street | 7842 HICKORY FLAT HWY STE. B |
| Manufacturer City | WOODSTOCK, GA |
| Manufacturer Country | US |
| Manufacturer Phone | 8372681 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERAFIX DURA SUBSTITUTE |
| Generic Name | CERAFIX |
| Product Code | GXQ |
| Date Received | 2020-02-11 |
| Model Number | C1-4X5 |
| Lot Number | 20147 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACERA SURGICAL, INC |
| Manufacturer Address | 7842 HICKORY FLAT HWY STE. B WOODSTOCK, GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-11 |