MAUDE Adverse Event Report: RENERVE RENERVE NERVALIGN; NERVE CUFF

Model Number	NA-NC3040
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Implant Pain (4561); Sinusitis (4844); Abnormal scarring (4896)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon implanted a 30x40mm nervalign nerve cuff on (b)(6) 2025 and the patient did not immediately report any issues post-operatively.The surgeon did not see the patient again until approximately on (b)(6) 2025 (~5 months), the patient reported significant pain and presented with hypertrophic scars.The surgeon revision procedure on (b)(6) 2025 was to address nerve entrapment presumed to be from a previous surgery, which he did not perform.The surgeon cut the 30x40mm cuff in half and used the material in both places where cutaneous scarring presents.Note: the nerve cuff is also provided in 10mmx10mm size, using membranes cut into half is not expected to be problematic.The linear incision (fully healed and just behind the malleolus) from the first surgery is observable at the patient's posterolateral ankle.The surgeon shared that his patient does have abnormal sensitivities / medication allergies to estradiol and norelgestromin.No previous keloid formation was observed following the primary procedure, and the patient did not share any known sensitivity to porcine materials.Since the patient continues to experience intermittent swelling and is 5-months post-op, the surgeon said he will likely plan a neurectomy and scar resection due to the significant fibrosis.The surgeon believes this occurrence to potentially be an allergic reaction.The actual name of the patient can be provided upon request.
Additional Manufacturer Narrative
The treating surgeon performed revision of another surgeons previous surgery, no device used and suggests a possible allergic reaction.No other adverse events have been reported for this lot (over (b)(4) sold).A review of the dhr indicates the device was manufactured to specification.There is insufficient information available to determine whether the device is responsible for the reported symptoms.

• Brand Name: RENERVE NERVALIGN
• Common Device Name: NERVE CUFF
• Manufacturer (Section D): RENERVE; level 10/99 queen st; melbourne, victoria 3000 ; AS 3000
• Manufacturer (Section G): EUROPEAN MEDICAL CONTRACT MANUFACTURING; middenkampweg 17,; ch; nijmegen, gelderland 6545 ; NL 6545
• Manufacturer Contact: james bennett ; level 10, 99 queen street; melbourne, vic 3000 ; AS 3000
• MDR Report Key: 24197164
• Report Number: 3022317591-2026-00001
• Device Sequence Number: 10016439
• Product Code: JXI
• UDI-Device Identifier: 09369998231904
• UDI-Public: (01)09369998231904(17)251231(10)23A0320028
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: 202234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: NA-NC3040
• Device Lot Number: 23A0210028
• 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: 07/29/2025
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Age: 40 YR
• Patient Sex: Female