ZERO-P VA CAGE LORDOTIC H9 PEEK
Received Jul 8, 2026 · Event occurred Jun 11, 2026
Report 8030965-2026-06874 · MDR key 25746200
Device
Generic name
Intervertebral Fusion Device With Integrated Fixation, Cervical
Manufacturer
Synthes GmbhCatalog number
04.647.129S
Lot number
82711P2
Product problems
- Detachment of Device or Device Component
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THE ZERO P IMPLANT CAME APART DURING THE IMPLANTATION. THE CONSULTANT REPRESENTATIVE EXPLAINED THAT THIS HAPPENS AS AN AID TO COMBAT STRESS RISERS POST OP. THE HOSPITAL THOUGHT IT BROKE AND DIDN'T REALIZE IT CAN COME APART AND COULD BE PUT BACK TOGETHER. THEY CHOSE A NEW IMPLANT AND IMPLANTED THE NEW IMPLANT. SURGERY WAS COMPLETED SUCCESSFULLY WITH A 5 MINUTE SURGICAL DELAY
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (b)(4).THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.