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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: POLYGANICS INNOVATIONS BV NEUROCAP; NERVE CUFF
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POLYGANICS INNOVATIONS BV NEUROCAP; NERVE CUFF Back to Search Results
Model Number NC01-025/03
Health Effect - Clinical Code No Code Available (3191)
Date of Event 04/02/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The intended use of the neurocap device is to protect a peripheral nerve end and separate the nerve from the surrounding environment to reduce the development of a symptomatic neuroma.This means there is still a chance to develop a recurrent neuroma.
 
Event or Problem Description
The patient had a right saphenous neurectomy with 3 neurocaps inserted at his initial surgery on (b)(6) 2018.He developed the recurrence of a neuroma which required a second operation to excise the neuroma.
 
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Brand Name
NEUROCAP
Common Device Name
NERVE CUFF
Manufacturer (Section D)
POLYGANICS INNOVATIONS BV
rozenburglaan 15a
groningen, 9727 DL
NL  9727 DL
MDR Report Key8891880
Report Number3004504732-2019-00001
Device Sequence Number1413233
Product Code JXI
UDI-Device Identifier08717703990256
UDI-Public08717703990256
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K152684
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source foreign,study
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/08/2019
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 Date10/11/2018
Device Model NumberNC01-025/03
Device Catalogue NumberNEUROCAP 2.5 MM
Device Lot NumberNCA2017040611
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/11/2019
Initial Report FDA Received Date08/14/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age50 YR
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