VIPER PRIME
Received Jul 27, 2026 · Event occurred Jul 2, 2026
Report 1526439-2026-01094 · MDR key 50020091
Device
Generic name
Orthosis, Spinal Pedicle Fixation, For Ddd
Manufacturer
Medos International Sã rl ChCatalog number
186760440S
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Cardiac Arrest
Narrative
Description of Event or Problem
It was reported a posterior spinal fusion (T9, T10, T12, L1) for fracture of the eleventh thoracic vertebra occurred on (b)(6) 2026.At the end of the cement injection, the patient experienced cardiac arrest and resuscitative measures were performed. No cement leakage was observed under fluoroscopy. The surgery was completed successfully without any surgical delay.This complaint is related to (b)(4) covers the SPN product, while (b)(4) covers the SPD product.
Additional Manufacturer Narrative
PRODUCT COMPLAINT #PC-002204899This 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.D4: UDI: As the lot number for the device involved in the event was not provided, the full UDI is currently not available.