MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. DURAMATRIX SUTURABLE; DURA SUBSTITUTE

Model Number DMS33

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fall (1848); Swelling (2091)

Event Date 08/31/2020

Event Type  malfunction  

Event Description

Patient underwent a chiari malformation repair in the first quarter of the year.On (b)(6) the patient fell forward hitting his head and a sudden meningocele developed at the operative site.A rapid mri showed a pseudomeningocele and likely a small defect at the site of the dural graft with some separation of the muscles.The hypothesis was that the muscles were attached to the dura/graft and might have been pulled during his fall, causing a small tear.The patient was observed and remained clinically well, with no further enlargement of the collection, which remained soft.Because the fluid collection persisted despite 8 weeks of conservative management, the patient underwent pseudomeningocele repair.During surgery a tear in the center of the graft was encountered, with intact suture line between graft and native dura.The center of the graft was resected back to fibrotic and/or vascularized tissue and a new cellulose dural graft was placed without difficulty.

• Brand Name: DURAMATRIX SUTURABLE
• Type of Device: DURA SUBSTITUTE
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton rd; oakland NJ 07436
• MDR Report Key: 10927116
• MDR Text Key: 218937642
• Report Number: 10927116
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/24/2020,11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DMS33
• Device Lot Number: 1902281121
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/24/2020
• Event Location: Other
• Date Report to Manufacturer: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1825 DA
• Patient Weight: 20