MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-06 for DURASEAL XACT, UNKNOWN XXX-DURASEAL XACT manufactured by Integra Lifesciences Corp.
[144179088]
The device is not expected to be returned to the manufacturer for evaluation. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[144179089]
A (b)(6) patient reported that she had an unspecified surgery on (b)(6) 2019 in which duraseal was used. She has had multiple magnetic resonance imagings (mris) post surgery and the surgeon has found a "glue mass" that formed inside her body. The patient stated she has spoken with her surgeon multiple times and wanted the duraseal removed but the surgeon would not remove the product. The patient reported that her pain has become worse since the surgery. She was having intense nerve pain on her spinal cord. Additional information was received on 03may2019 with the following: information from operative notes indicated that prior to dural closure, morphine and clonidine were injected into the intrathecal space to assist with pain control. Valsalva maneuver to 40 mmhg was performed to ensure that there was no active cerebrospinal fluid (csf) leak. The dural opening was then covered using duraseal. Hemostasis was again obtained using bipolar cautery as well as floseal packing with a cottonoid. To this point in the operation, there were no neuromonitoring changes. The patient reported that the mass was discovered one and a half weeks after surgery as symptoms progressed and it was seen on mri; the surgeon told the patient? It was just glue?. The patient reported she was 14 weeks post surgery and still had a mass that was tethering her spinal cord to her lamina, making it impossible to stand and walk for any period of time. The patient stated she was told by her surgeon that? A lot? Of duraseal was used and was advised that it would be gone at 12 weeks. The patient reported her pain level being 10 out of 10. She stated that she was watching the mass closely for another two weeks before scheduling a revision surgery. The mass has reduced in size by about one third (1/3) over 14 weeks. It has gone from completely compressing her thecal sack to sitting on it and it? S adhesive properties were making any movement excruciating. She stated that the glue completely displaced her nerves from l4/l5 down.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2019-00014 |
| MDR Report Key | 8583496 |
| Report Source | CONSUMER |
| Date Received | 2019-05-06 |
| Date of Report | 2019-04-10 |
| Date Mfgr Received | 2019-11-01 |
| Date Added to Maude | 2019-05-06 |
| 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. VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362319 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORP |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURASEAL XACT, UNKNOWN |
| Generic Name | DURASEAL SPINE |
| Product Code | NQR |
| Date Received | 2019-05-06 |
| Catalog Number | XXX-DURASEAL XACT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORP |
| Manufacturer Address | 311 ENTERPRISE DRIVE 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-06 |