AMPRecalls & reported problems across all models

We found 5 models of AMP by Alphatec Spine, Inc. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Feb 16, 2022 and Jun 16, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

AMP recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 7, 2023Open, Classified

   Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft advancement stop, which may lead to over insertion, dural tear, vascular/neurologic injury, adjacent tissue damage, increased operative time, revision surgery.

   Z-2475-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported AMP problems

AMP models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AMP 117-165

  AWL
  1 recall0 reports
• AMP 117-160

  BIT, DRILL
  1 report
• AMP 116-4-5545

  Intervertebral fusion device with integrated fixation, lumbar
  1 report
• AMP 116-4-6545

  Intervertebral fusion device with integrated fixation, lumbar
  1 report
• AMP 116-1-3-06-S

  Intervertebral fusion device with integrated fixation, lumbar
  1 report

Recent AMP adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2022Fracture; Fracture

  IT WAS REPORTED THE THREADED PORTION OF THE SCREW BROKE DURING INSERTION. IT REMAINS IN SITU AS IT COULD NOT BE RETRIEVED FROM THE CAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14723340 ↗
• MalfunctionMay 27, 2022Break; Break

  DURING AN L4/L5 LIF SURGERY, THE AMP BONE SCREW BROKE IN THE PATIENT AT THE L5 VERTEBRAL BODY. THE SCREW SHANK WAS LEFT IN THE PATIENT AND THE SCREW HEAD WAS RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14526932 ↗
• MalfunctionMay 9, 2022Material Twisted/Bent; Material Twisted/Bent

  BOTH THE AWL AND DRILL BENT WHILE TRYING TO PUT A LATERAL PLATE ON CAUSING A DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342470 ↗
• InjuryFeb 16, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AROUND 10 MONTHS POSTOPERATIVELY, RADIOGRAPHS REVEALED A SELF-RETAINING CAUDAL SCREW HAD BACKED OUT OF THE PLATE. THE LOCKING MECHANISM ARM ON THE PLATE ALSO APPEARED TO BE BROKEN. A REVISION SURGERY TOOK PLACE ON (B)(6) 2022 TO REMOVE AND REPLACE THE IMPLANTS.

  Patient problems: Insufficient Information

  MAUDE report 13546062 ↗

Other Alphatec Spine, Inc. products

• Invictus96 models · 448 reports
• IdentiTi31 models · 68 reports · 1 recall
• ATEC Lateral Navigation Disc Prep Instruments2 models · 0 reports · 2 recalls
• Calibrate44 models · 40 reports · 1 recall
• Arsenal18 models · 86 reports
• Illico20 models · 69 reports
• Insignia34 models · 54 reports
• Trestle Luxe24 models · 38 reports