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.
11 linked reportsMalfunction 11
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
5
2019-03
0
2
2019-04
0
4.5
2019-05
0
2.33
2019-06
0
2
2019-07
0
1
2019-08
0
2.33
2019-09
0
1.5
2019-10
0
2
2019-11
0
2
2019-12
2
2.33
2020-01
0
2.75
2020-02
0
1.33
2020-03
0
1.5
2020-04
0
3
2020-06
0
3
2020-08
0
1.67
2020-09
0
1.71
2020-10
0
2
2020-11
0
3
2020-12
0
2.33
2021-01
0
3
2021-02
0
2
2021-03
0
3
2021-04
0
3
2021-05
0
2
2021-06
0
2.67
2021-07
0
3.25
2021-08
0
2.33
2021-09
0
2.33
2021-10
0
1
2021-11
0
2.5
2021-12
0
2.33
2022-01
0
1.5
2022-02
0
1
2022-04
0
2.5
2022-05
0
1
2022-06
0
2.5
2022-07
0
3
2022-08
0
2
2022-09
0
3.33
2022-10
0
1.67
2022-11
0
1.33
2022-12
0
2.14
2023-01
0
1.78
2023-02
0
2.33
2023-03
0
2.67
2023-04
0
2.33
2023-05
0
3
2023-06
0
3
2023-07
2
2.5
2023-08
0
1.5
2023-10
0
1
2023-11
0
2.5
2023-12
0
2
2024-01
0
2
2024-02
0
2
2024-03
0
1
2024-04
0
1
2024-05
0
1.5
2024-06
0
1
2024-07
0
2.67
2024-08
0
1
2024-09
0
1.75
2024-10
0
1
2024-11
0
1.33
2025-02
0
2.5
2025-03
0
1.67
2025-04
0
2
2025-05
2
2
2025-06
0
4
2025-07
0
2
2025-08
0
1.5
2025-09
0
1.5
2025-10
1
1.5
2025-11
0
3.33
2025-12
2
3.33
2026-01
0
1
2026-02
0
1.33
2026-03
0
2
2026-04
0
1.75
2026-06
2
1.75
This device (reports/month)Average device in HXB (reports/device/month)
Failure-mode summaryAI-generated
11 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
Date
Report #
Type
Narrative
Link basis
2026-06-11
2027467-2026-00128
Malfunction
Available
exact di
2025-12-16
2027467-2025-00262
Malfunction
Available
exact di
2025-10-08
2027467-2025-00227
Malfunction
Available
model number
2025-05-29
2027467-2025-00111
Malfunction
Available
exact di
2023-07-24
2027467-2023-00047
Malfunction
Available
exact di
2019-12-26
2027467-2019-00061
Malfunction
Available
exact di
Showing the most recent 6 of 11 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
Date
Type
Outcome
Facility
Citations
2017-04-19
VAI
Voluntary action indicated
Alphatec Spine, Inc.
1
2016-03-16
VAI
Voluntary action indicated
Alphatec Spine, Inc.
1
2015-07-16
WL
Warning Letter
Alphatec Spine, Inc.
—
2015-03-13
OAI
Official action indicated
Alphatec Spine, Inc.
0
2013-06-14
NAI
No action indicated
Alphatec Spine, Inc.
0
2012-04-27
VAI
Voluntary action indicated
Alphatec Spine, Inc.
0
2011-01-11
WL
Warning Letter
Alphatec Spine, Inc.
—
2010-12-13
VAI
Voluntary action indicated
Alphatec Spine, Inc.
7
2010-06-21
WL
Warning Letter
Alphatec Spine, Inc.
—
2010-02-11
OAI
Official action indicated
Alphatec Spine, Inc.
11
Similar devices
Hip Angled ProbeT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Hip Curved ProbeT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Hip Straight ProbeT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
4mm Probe 90°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION