MalfunctionNKB
PERLA TL
Received Jul 6, 2026
Report 3007728266-2026-00008 · MDR key 25714138
Device
Generic name
Setscrew
Manufacturer
Spineart SaModel number
TLF-SC 00 00-SCatalog number
TLF-SC 00 00-S
Lot number
UNKNOWN
Product problems
- Migration
Patient
NA · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
WE RECEIVED A COMPLAINT FROM THE US ON (B)(6) 2026 (REGISTERED UNDER (B)(4)) REPORTING THAT DURING PATIENT'S FOLLOW UP VISIT, X-RAYS PICTURES SHOWS SET SCREW POPPED OFF INSIDE PATIENT. NO OTHER INFORMATION AVAILABLE (NO DATE, NO LOT NUMBER, NO HEALTH IMPACT REPORTED). PENDING ADDITIONAL INFORMATION. LATE SUBMISSION (THE REPORT SHOULD HAVE BEEN SUBMITTED BY (B)(6) 2026; THIS ISSUE HAS BEEN ADDRESSED UNDER (B)(4)).