TI MATRIXNEURO SCREW SELF-DRILLING 4MM
Received Jul 31, 2026 · Event occurred Jun 29, 2026
Report 8030965-2026-07878 · MDR key 50103065
Device
Generic name
Plate, Cranioplasty, Preformed, Alterable
Manufacturer
Synthes GmbhCatalog number
04.503.104.01C
Lot number
117579P
Product problems
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that the screw broke during an extravertebroplasty surgery. All the pieces were removed from the patient. Another device was used to complete the surgery. There were no adverse consequences to the patient. There was no surgical delay. No additional information could be provided.
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.