FDA Adverse Event Injury Summary report: N

MOBI-C IMPLANT; SIZE UNKNOWN

MDR report key: 24152775 · Received January 22, 2026

Report

Report Number: 3004788213-2026-00007
Event Type: Injury
Date Received: January 22, 2026
Report Date: January 21, 2026
Manufacturer: LDR MEDICAL
Product Code: MJO
PMA / PMN Number: SEEH10
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

D4: THE UDI NUMBER IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS ARE NOT AVAILABLE. G4: THIS DEVICE IS NOT CLEARED FOR USE IN OR MARKETED WITHIN THE US, HOWEVER IT IS A SIMILAR PRODUCT TO THOSE CLEARED BY P110009 UNDER PRODUCT CODE MJO. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REFERENCE ARTICLE: KIM, K.R., CHIN, D.K., KIM, K.S., CHO, Y.E., SHIN, D.A., KIM, K.N., & KUH, S.U. (2021). REVISION SURGERY FOR A FAILED ARTIFICIAL DISC. YONSEI MEDICAL JOURNAL 62(3). HTTPS://DOI.ORG/10.3349/YMJ.2021.62.3.240.

Description of Event or Problem · 0

IT WAS REPORTED THAT A MOBI-C IMPLANT AT C5-6 FAILED APPROXIMATELY 4 YEARS POST-OPERATIVELY; THE PATIENT HAD AN IMPROPER INDICATION OF SPONDYLOSIS PRIOR TO INSTALLING THE IMPLANT. A REVISION SURGERY WAS PERFORMED WHERE A LAMINOPLASTY WAS PERFORMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
210396	MOBI-C IMPLANT; SIZE UNKNOWN	PROSTHESIS, INTERVERTEBRAL DISC	MJO	LDR MEDICAL	NA	NI

Patients

Seq	Age	Sex	Outcome	Treatment
1	41 YR	Female	Required Intervention\| O\| H