KONG-TL VBR System, Screwdriver for Locking Screw · recalls, adverse events, clearances

Regulatory presence across jurisdictions

The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.

European UnionKONG®-TL VBR System Screwdriver for Locking Screw764017255iVBRTL0012XL

Adverse-event reports (MAUDE)

Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

15 linked reportsMalfunction 11Injury 4

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	0	2
2019-02	0	1.38
2019-03	0	2.14
2019-04	0	1
2019-05	0	1.57
2019-06	0	2.14
2019-07	0	1.36
2019-08	0	2
2019-09	0	1
2019-10	0	1.33
2019-11	0	1
2019-12	0	1.54
2020-01	0	1.63
2020-02	0	1.17
2020-03	0	1.67
2020-04	0	1.33
2020-05	0	1.17
2020-06	0	1.3
2020-07	0	2.69
2020-08	0	1.69
2020-09	0	1.53
2020-10	0	1.69
2020-11	0	1.22
2020-12	0	1.56
2021-01	0	1.29
2021-02	0	1.29
2021-03	0	1.8
2021-04	0	1.48
2021-05	0	1.26
2021-06	0	3.17
2021-07	0	1.73
2021-08	0	1.64
2021-09	0	1.33
2021-10	0	1.67
2021-11	0	1.45
2021-12	0	1.41
2022-01	0	1.38
2022-02	0	1.52
2022-03	0	1.66
2022-04	0	1.58
2022-05	0	1.63
2022-06	0	1.58
2022-07	0	1.41
2022-08	0	1.4
2022-09	0	2.29
2022-10	4	1.56
2022-11	0	1.8
2022-12	0	1.3
2023-01	0	2
2023-02	0	1.44
2023-03	4	3.64
2023-04	0	1.17
2023-05	0	1.33
2023-06	0	1.2
2023-07	4	2.33
2023-08	0	1.7
2023-09	0	1.63
2023-10	0	1.67
2023-11	0	1.22
2023-12	0	1.35
2024-01	0	1.8
2024-02	0	1.7
2024-03	0	2
2024-04	0	1.45
2024-05	0	2.25
2024-06	0	1.43
2024-07	0	1.5
2024-08	0	1.07
2024-09	0	1.46
2024-10	0	1.29
2024-11	0	1.3
2024-12	0	1.4
2025-01	0	1.36
2025-02	0	1.69
2025-03	0	3.53
2025-04	0	1.9
2025-05	0	2.26
2025-06	0	1.57
2025-07	0	1.45
2025-08	3	1.88
2025-09	0	1.56
2025-10	0	1.56
2025-11	0	1.5
2025-12	0	1.53
2026-01	0	1.35
2026-02	0	1.23
2026-03	0	1.84
2026-04	0	1.76
2026-05	0	1.67
2026-06	0	1.75

This device (reports/month)Average device in MQP, PLR (reports/device/month)

Failure-mode summaryAI-generated

15 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-08-21	3006493760-2025-00004	Malfunction	Available	exact di
2023-07-28	3006493760-2023-00002	Injury	Available	catalog number
2023-03-07	3006493760-2023-00001	Malfunction	Available	catalog number
2022-10-28	3006493760-2022-00002	Malfunction	Available	catalog number

Showing the most recent 4 of 15 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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