MAUDE Adverse Event Report: INTEGRA - PRINCETON DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 2; N/A

Catalog Number	DURS2291
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/02/2025
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
This report is 1 of 6 for duragen (durs2291) and is linked to mfg report numbers: 3006697299-2025-00004, 3006697299-2025-00005, 3006697299-2025-00006, 3004608878-2025-00010, 3006697299-2025-00009.A facility reported that during craniotomy cases they have been seeing post-operative infections ¿curtibacterium acnes bacteria¿ all involving the same doctor after using cusa devices and duragen.The integra account manager (iam) asked if they had been looking at their devices since he observed that they were not cleaning the mayfield equipment properly.As a result, the iam provided both the mayfield and cusa cleaning instructions to the facility.The customer is not sure which device may be causing the infections but are also using other manufacturer¿s products and have contacted them as well.During preoperative support for another case, the iam did observe that the opened cusa tray on the sterile field had a previously used tip still attached to the cusa 23k handpiece, and there was a previously used disposable wrench also in the tray.The surgical team had to break down the sterile field and sent all the items back to spd.The facility is primarily concerned with ensuring the cusa is being handled and cleaned properly and consistently, and the iam has arranged to provide retraining to the staff on all involved products used during the cases.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h11.Additional information has been received indicating the following: do you know where on patient¿s body the infection occurred (site of infection)? i do not know that formally, but it¿s been stated in conversations between staff and surgeon that it was within the surgical site (head/brain).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.Duragen suturable dural regeneration template (durs1391)) was not returned for evaluation; however, investigation of retained samples was performed as follows: device history record (dhr) review - the dhr was reviewed, and no anomalies were found during the manufacturing and packaging process that could be related to the reported condition.Failure analysis - one (1) unit was visually inspected.Dispenser box and tray are in good condition, both trays (outer and inner) sealing area are complete, no sponge defect was observed, and product labeling information was correct including expiration date.No defects in overall were observed.Medical assessment - a medical assessment was performed to evaluate the possible relation between the reported event and product use.The assessment concludes the following: ¿based on the complaint information received to date, evidence does not suggest a causal relationship to duragen but to other factors primarily, as reported and observed by the integra sales representative, of equipment not being cleaned properly by the facility personnel (i.E., cleaning of mayfield equipment in the scrub sink, wiped with wipes, and not being sent to the sterile processing department; prior to start of procedure, ¿cusa tray opened on the sterile field had a previously used tip still attached to the 23k handpiece, and there was a previously used disposable wrench also in the tray¿).Also, non-integra devices cannot be ruled out as causal.It is noteworthy that the customer reported seeing post-op infection during craniotomy procedures involving the same physician with the same type of infection in all cases.During a conversation between the integra sales representative and the neurosurgeon, the neurosurgeon confirmed two recent infection cases, both with commensal curtibacterium acnes.Curtibacterium acnes is a common pathogen that is found on skin, hair follicles, and sebaceous glands, which can stay in the dermal layer in spite of standard surgical skin preparation.It has been increasingly recognized as a cause of surgical site infections (ssi)2.According to literature, the incidence of surgical site infections after craniotomy (ssi-cran) ranges from 2.2 to 19.8%.¿ root cause - based on the available information, the satisfactory retain sample results, and the conclusion of the medical assessment, the evidence does not suggest that the duragen suturable product was causal to the reported event but to other factors primarily, (i.E., equipment not being cleaned properly as reported and observed by the integra sales representative).Additionally, infection is a known possible complication with any neurosurgical procedure.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 2
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ 08540
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ 08540
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21283438
• Report Number: 1121308-2025-00001
• Device Sequence Number: 18088207
• Product Code: GXQ
• UDI-Device Identifier: 10381780023500
• UDI-Public: 10381780023500
• Combination Product (Y/N): N
• PMA/510(K) Number: K043427
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: DURS2291
• Device Lot Number: 7212759
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: 01/24/2025; 03/05/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 02/20/2025; 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2023
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: C7300 CUSA CLARITY TUBING SET; C7418S CUSA CLARITY TIP; C7523X CUSA CLARITY NOSECONE; C7601 CUSA CLARITY WRENCH; UNKNOWN MAYFIELD SKULL CLAMP
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown