PIVOX™ Oblique Lateral Spinal System 2140020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169639553), received between Nov 5, 2019 and Mar 27, 2020 — classified as 2 malfunctions.

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

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L2-L3 DEGENERATIVE DISC AND FORAMINAL STENOSIS AT L2-L3. SHE UNDERWENT OBLIQUE LATERAL/DIRECT LATERAL INTERBODY FUSION AT L2-L3. INTRA-OP, THE CONNECTION BETWEEN THE INSTRUMENT AND THE IMPLANT BROKE. NO FRAGMENT OF THE INSTRUMENT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9887433 ↗
• MalfunctionNov 5, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH DEGENERATIVE DISK DISEASE (DDD), SPONDY AT L4/5 AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF) SURGERY AT L4/5. DURING SURGERY, BLACK TAB LOCKING PART TO OUTER SLEEVE BROKE OFF. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE INSTRUMENT REMAINED IN THE PATIENT BODY. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9277031 ↗