Precept 8896545Recalls & reported problems
Nuvasive, Inc. · PRECEPT Screw Shank, 6.5x45mm Modular · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517387547), received between Jun 9, 2016 and Jun 9, 2016 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pain1
- Unspecified Infection1
- Wound Dehiscence1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IN (B)(6) 2015 A (B)(6) MALE HAD A PROCEDURE DONE FOR A BULGING DISC, SPINE LEVEL UNKNOWN. ON (B)(6) 2015 THE PATIENT WAS IMPLANTED WITH A POSTERIOR FIXATION AT L4-L5. NO COMPLICATIONS WERE NOTED BASED ON SURGEON'S OPERATIVE NOTES. ON (B)(6) 2015 AN INTERVENTION TOOK PLACE FOR THE INCISION AND DRAINAGE OF THE LUMBAR WOUND. NO NECTROTIC TISSUE WAS VISUALIZED. BACITRACIN INFUSED SALINE WAS USED TO IRRIGATE THE WOUND COPIOUSLY. CULTURE RESULTS SHOWED LIGHT GROWTH OF ESCHERICHIA COLI. PATIENT WAS TREATED WITH WOUND VACS IN THE LEFT LATERAL AND MIDLINE OF THE BACK. ADDITIONAL UNKNOWN ANTIBIOTIC TREATMENT WAS PRESCRIBED FOLLOWING WOUND DEBRIDEMENT . WOUND REPORTEDLY HEALED IN (B)(6) 2016.
Patient problems: Pain; Unspecified Infection; Wound Dehiscence
MAUDE report 5709724 ↗
Other Orthosis, spondylolisthesis spinal fixation devices
- CD HORIZON® Spinal System 7540020Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation257 reports
- MANTIS Redux 48289999Stryker Corporation · Orthosis, spondylolisthesis spinal fixation76 reports
- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.