CLYDESDALE PTC™ Spinal System 4922250Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169191327), received between Nov 10, 2017 and Jul 26, 2019 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION AT L4-L5 DUE TO LUMBAR KYPHOSIS. INTRA-OP, POSTERIOR PART OF THE CAGE BROKE WHILE INSERTING IT USING THE INSERTER. THE BROKEN PART OF THE CAGE WAS REMOVED; AND THE REST WAS LEFT INDWELT IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8830675 ↗
• MalfunctionMar 8, 2019Break; Break

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: CAGE BACKED OUT PROCEDURE: OBLIQUE LUMBAR INTERBODY FUSION (OLIF) LEVELS IMPLANTED: L2/3/4 IT WAS REPORTED THAT INTRA-OP, DURING REVISION SURGERY THE POSTERIOR PART OF THE CAGE BROKE ON INSERTION. WHILE REMOVING THE INSERTER, IT WAS CONFIRMED THAT THE NEWLY INSERTED CAGE BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8402928 ↗
• InjuryJan 7, 2019Malposition of Device; Malposition of Device

  PRE-OPERATIVE DIAGNOSIS: DEGENERATIVE SCOLIOSIS PROCEDURE: L1-5 ANTEROPOSTERIOR FUSION. L1-5 OBLIQUE LUMBAR INTERBODY FUSION (OLIF), PERFORMED PPS ON POSTERIOR SIDE. LEVEL IMPLANTED: L1-5 INTRAOPERATIVE BLEEDING VOLUME: 3300CC IN TOTAL (2500CC DURING OLIF, 800CC DURING PPS) IT WAS REPORTED THAT INTRA-OP, AFTER PLACING THE CAGE AT L4/5, THE CAGE PROCEEDED TO THE CONTRALATERAL SIDE. IT WAS CONFIRMED BY THE FRONTAL IMAGE BY INTRAOPERATIVE C ARM THAT 3/4 OF THE CAGE PROTRUDED TO THE CONTRALATERAL SIDE. CAGE WAS TRIED TO BE REMOVED FROM THE INVADING SIDE, BUT IT DID NOT MOVE AT ALL. AT THIS TIME, THE BLOOD PRESSURE DROPPED NOTICEABLY AND REMOVAL FROM THE INVADING SIDE WAS GIVEN UP. BECAUSE RISKS SUCH AS BLEEDING WERE ALSO CONSIDERED, SO THE WOUND WAS CLOSED AND CONFIRMED BY CT. THE OVERALL OPERATION TIME WAS DELAYED ABOUT TWO AND A HALF HOURS. ADDITIONAL SURGERY WAS PERFORMED BY CHANGING THE PATIENTS POSITIONS FROM THE CONTRALATERAL SIDE AND SINCE THERE WAS NO PROBLEM IN THE CAGE ITSELF, THE CAGE WAS IMPLANTED INTO THE PATIENT AS IT WAS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8224514 ↗
• MalfunctionMar 14, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION - OLIF AT L3/4 DUE TO DEGENERATIVE SCOLIOSIS. INTRA-OP, WHEN TRYING TO PULL THE CAGE OUT AFTER INSERTING IT INTO THE INTERVERTEBRAL SPACE, IT BROKE. THE CAGE WAS BROKEN FROM THE THREAD PART, AND IT REMAINED THERE EVEN THOUGH IT WAS TRIED TO BE REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7337817 ↗
• MalfunctionFeb 23, 2018Break; Break

  PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: SPINAL CANAL STENOSIS TYPE OF PROCEDURE OR TECHNIQUE USED : LUMBAR ANTEROPOSTERIOR FUSION LEVELS IMPLANTED: L2-4 IT WAS REPORTED THAT INTRA-OP, AFTER INSERTING THE CAGE, THERE WAS SOMETHING THAT LOOKED LIKE SPRING, CAME OUT FROM THE CONNECTION PART BETWEEN INSERTER AND CAGE. IT APPEARED TO BE A FRAGMENT OF SCREW THREAD OF THE CAGE. NO FRAGMENTS REMAINED IN THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7292425 ↗
• MalfunctionNov 10, 2017Break; Break

  PRE-OPERATIVE DIAGNOSIS: SPINAL CANAL STENOSIS(L4-L5). THE TYPE OF PROCEDURE: OLIF (OBLIQUE LUMBAR INTERBODY FUSION). LEVELS IMPLANTED: L4-L5. IT WAS REPORTED THAT DURING SURGERY, THE THREAD OF THE CAGE WAS BROKEN DUE TO WHICH THE CAGE COULD NOT BE HELD WITH THE INSERTER. THE SURGEON PLACED THE CAGE IN PROPER POSITION WITH A REMOVER. DUE TO THE EVENT THERE WAS DELAY IN OVERALL PROCEDURE TIME OF LESS THAN 60 MIN. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7017947 ↗