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	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	08/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient experienced necrosis post surgery with spinal implants made by depuy spine (j&j) products.Avitene was also used in the procedure.The patient presented post-op with disengagement of the left-sided rod from her l3 pedicle screw and the patient's coronal balance also appeared to be significantly affected.The instructions for use provided with the avitene product lists a precaution on using avitene in the cns; avoid packing avitene¿ tightly in cavities, especially within the bony enclosure of the cns or within other relatively rigid cavities where swelling may interfere with normal function or possibly cause necrosis.It is unknow how or were in the product was used during the procedure.Based on the information provided, no conclusion can be made as to the extent to which the use of avitene powder during the spinal surgery may have caused or contributed to the patient's alleged postoperative necrosis.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in nov, 2019.This mdr represents the avitene (device #1).An additional mdr was submitted to represent the avitene (device #2).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
Per medwatch report (mw5154685): on or about (b)(6) 2020 a depuy spinal was used in patient surgery.Upon information, the product used in patient surgery include depuy expedium, cobalt chromium rods, uniaxial pedicel screws, depuy spine screws, rod viper straight and or other associated devices.The patient had some pain postoperatively and also had descriptions of cracking and popping involving her lumbosacral spine.X-ray revealed a disengagement of the left-sided rod from her l3 pedicle screw and the patient's coronal balance also appeared to be significantly affected.Patient was caused to sustain severe, serious, permanent injuries that had rendered her sick lore, lame and disabled.Also noted the patient experienced necrosis.On (b)(6) 2020 the patient underwent reinsertion of spinal fixation device with revision of instrumentation due to posterior instrumented spinal fusion hardware failure.On (b)(6) 2020 the patient underwent excisional debridement of skin including the subcutaneous level and fascia, right side and left side."this report reflects information received by fda in the form of a notification per 803.22 (b)(2)." note: the complaint reported failure of spinal implants made by depuy spine (j&j) products.The post-op conditions of implant failure (rod dissociation from the pedicle screws) are not an adverse event related to use of hemostat in the procedure.Bd complaint has been processed for avitene based on the allegation, "the patient experienced necrosis.".

• 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: 19520170
• Report Number: 1213643-2024-00302
• Device Sequence Number: 15588520
• Product Code: LMF
• UDI-Device Identifier: 00801741000386
• UDI-Public: (01)00801741000386
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2024

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 Expiration Date: 09/28/2022
• Device Catalogue Number: 1010020
• Device Lot Number: WBDW0036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2019
• 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 Sex: Female