MAUDE Adverse Event Report: INTEGRA - PRINCETON DURASEAL XACT, UNKNOWN; DURASEAL SPINE

Catalog Number XXX-DURASEAL XACT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intervertebral Disc Compression or Protrusion (4524)

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

World journal of clinical cases published an article: "cauda equina syndrome caused by the application of duraseal in a microlaminectomy surgery: a case report".Background - the management of dural tears is important.While a massive dura can be repaired with absorbable suture lines, cerebrospinal fluid leakage can be attenuated by dural sealant when an unintended tiny durotomy occurs intraoper­atively.Duraseal is often used because it can expand to seal tears.This case emphasizes the need for caution when duraseal is used as high expansion can cause complications following microlaminectomy.Case summary - a 77-year-old woman presented with l2/3 and l3/ 4 lateral recess stenosis.She underwent microlaminectomy, foraminal decompression, and disk height restoration using an intraspine device.A tiny incident durotomy occurred intraoperatively and was sealed using duraseal.However, decreased muscle power, urinary incontinence, and absence of anal reflexes were observed postoperatively.Emergent magnetic resonance imaging revealed fluid collection causing thecal sac indentation and central canal compression.Surgical exploration revealed that the gel-like duraseal had entrapped the hematoma and, consequently, compressed the thecal sac and nerve roots.While we removed all duraseal and exposed the nerve root, the patient's neurological function did not recover postoperatively.Adverse event ¿ the patient had no neurological discomfort one day after surgery; however, the following day, bilateral lower-extremity numbness and weakness occurred.The medical research council (mrc) scale of muscle power decreased from 5 to 2 (5: normal muscle power, 2: active movement with gravity eliminated) on the distal muscles in the bilateral lower extremities and deteriorated gradually.We attempted to remove urine from the foley tube, but urinary retention was observed.The residual urine volume was > 200 cc.In addition, the bulbocavernosus and anal reflexes were absent.The neurological dysfunction might not have been related to the intraoperative decompression and disk height restoration using an intraspine device because the symptoms did not appear immediately but rather 2 days after the surgery.Based on these observations, ces was suspected.An emergent t2-weighted phase mri examination revealed regional fluid collection at the surgical bed, protruding anteriorly at the junction of l2 and l3 to l4 levels.This fluid caused thecal sac indentation and narrowing of the central canal.Therefore, emergent exploration and decompression of the thecal sac were performed.Intraoperatively, a large amount of gel-like duraseal had formed a layer around the thecal sac and entrapped the extradural hematoma, resulting in spinal cord compression.We removed all duraseal, exposing the bilateral l3 and l4 nerve roots, and ensured that no duraseal material was compressing the nerve roots.Outcome and follow-up - unfortunately, although the patient was undergoing rehabilitation and physical therapy was initiated, muscle power and urinary and stool incontinence persisted for four months postoperatively.Her american spinal injury association score was a.Conclusion- duraseal expansion must not be underestimated.Changes in neurological status require investigation for cauda equina syndrome due to expansion.Doi: 10.12998/wjcc.V10.I30.11178.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d9, g6, h2, h3, h6, h10 xact, unknown (xxx-duraseal) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.A trending was performed as part of the evaluation.Proper finished good testing was performed prior to release as indicated in the dhr.Product was not received for analysis and the investigation could not confirm the complaint.Per the dfmea, potential causes of failure include: performance, reconstitution time.The risk remains acceptable per the risk analysis.Should new information becomes available, the file will be re-opened and the investigation summary will be amended as appropriate.

• Brand Name: DURASEAL XACT, UNKNOWN
• Type of Device: DURASEAL SPINE
• Manufacturer (Section D): INTEGRA - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16690617
• MDR Text Key: 312801887
• Report Number: 3003418325-2023-00007
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• PMA/PMN Number: P080013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-DURASEAL XACT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female