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CRANIOPLASTIC

Model 43-1280 · Cerenovus, Inc. · DI 10886704015505

GXP — Methyl Methacrylate For Cranioplasty · Class II · 21 CFR 882.5300

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (1)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

Malfunction: 1

12342019-01: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 4.25/device2020-11: 0 reports for this device; peer average 3/device2021-02: 0 reports for this device; peer average 1.5/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 3/device2021-11: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1/device2024-04: 1 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1.6/device2025-10: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 1/device0103050611120102050811020304050711030607040710100206
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0301
2019-0501
2019-0601
2019-1101
2019-1201
2020-0102
2020-0201
2020-0501
2020-0804.25
2020-1103
2021-0201.5
2021-0302
2021-0401
2021-0502
2021-0703
2021-1102
2022-0301
2022-0601
2023-0701
2024-0411
2024-0701
2024-1001.6
2025-1001
2026-0202
2026-0601
This device (reports/month)Average device in GXP (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Cerenovus, Inc.

  • NAI 2025-05-02 Cerenovus · 0 citations
  • VAI 2016-09-30 Cerenovus Inc · 1 citations
  • VAI 2016-09-21 Cerenovus, Inc. · 1 citations
  • VAI 2016-09-21 Cerenovus, Inc. · 1 citations
  • NAI 2015-10-22 Cerenovus Inc · 0 citations
  • NAI 2015-10-22 Cerenovus Inc · 0 citations
  • VAI 2014-03-14 Cerenovus Inc · 4 citations
  • VAI 2013-11-05 Cerenovus, Inc. · 6 citations
  • VAI 2013-11-05 Cerenovus, Inc. · 6 citations
  • NAI 2011-09-27 Cerenovus, Inc. · 0 citations
  • NAI 2011-09-27 Cerenovus, Inc. · 0 citations
  • VAI 2011-03-04 Cerenovus, Inc. · 1 citations
  • VAI 2011-03-04 Cerenovus, Inc. · 1 citations
  • VAI 2010-12-30 Cerenovus Inc · 7 citations
  • NAI 2010-06-17 Cerenovus, Inc. · 0 citations
  • NAI 2010-06-17 Cerenovus, Inc. · 0 citations