MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 AVITENE; AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED

Catalog Number	1010020
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Intervertebral Disc Compression or Protrusion (4524)
Date of Event	10/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, patient had pain, weakness in arm, spinal cord compression post usage of avitene and underwent additional surgery.Based on the information available, the user moistened the avitene flour with saline and thrombin.The surgeon also did not remove excess avitene material following hemostasis.As prescribed in the instructions-for-use supplied with the device avitene flour should be used in a dry state and any excess material should be removed.Root cause of the report event is the result of moistening / wetting the product prior to use and leaving excess material at the site by the surgeon.No lot number has been provided; therefore, a review of the manufacturing records is not possible the warnings section of the instructions-for-use (ifu) supplied with the device states "moistening mch or wetting with saline or thrombin impairs its hemostatic efficacy.It should be used dry." per the precautions section of the ifu, "only that amount of avitene¿ (mch) necessary to produce hemostasis should be used.After several minutes, excess material should be removed.Any excess avitene¿ (mch) not removed at the time of surgery may either present itself as a (recurring) mass or a (space occupying) lesion or it may lead to a foreign body reaction." note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported, the patient underwent the anterior cervical discectomy and fusion (acdf) procedure on (b)(6) 2023.Avitene flour 1 gram mixed with saline and thrombin was used (off label per ifu).The surgeon left excess avitene in and seeped into the epidural space leading to spinal cord compression.Post usage patient experienced pain and weakness in arm and underwent additional surgery on (b)(6) 2023 which included a corpectomy.No other hemostatic agents or products were used.

• Brand Name: AVITENE
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): DAVOL INC. -1223089; 160 new boston st.; woburn MA 01801
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 18291237
• Report Number: 1213643-2023-00479
• Device Sequence Number: 6667576
• Product Code: LMF
• UDI-Device Identifier: 00801741000386
• UDI-Public: (01)00801741000386
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: N17600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1010020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male