MOBI-C IMPLANT M"STANDARD" SIZE UNKNOWN
Report
- Report Number
- 3004788213-2025-00025
- Event Type
- Injury
- Date Received
- May 6, 2025
- Date of Event
- January 14, 2025
- Report Date
- August 3, 2025
- Manufacturer
- LDR MEDICAL
- Product Code
- MJO
- PMA / PMN Number
- SEEH10
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- 003
Narratives
D4 UDI NUMBER: 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 REPORT 3004788213-2025-00024.
ADDITIONAL INFORMATION IN H6: INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED AND NO PHOTOS WERE PROVIDED, SO AN EVALUATION IS UNABLE TO BE PERFORMED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED BECAUSE OF THE LACK OF INFORMATION PROVIDED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO THE REPORTED FAILURE OF THE IMPLANT HOLDER, CAUSING THE PROSTHESIS TO BE PUSHED PAST POSTERIOR WALL OF THE VERTEBRAL BODY AND COMPRESSING THE SPINAL CORD. THIS EVENT COULD ALSO POSSIBLY BE ATTRIBUTED TO UNKNOWN PATIENT OR SURGICAL FACTORS. DHR REVIEW: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS NOT REPORTED, THEREFORE A DHR IS UNABLE TO BE LOCATED FOR REVIEW. DEVICE USAGE: THIS DEVICE IS USED FOR TREATMENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SENT.
IT WAS REPORTED THAT A PATIENT UNDERWENT A C5-C6 ANTERIOR CERVICAL SPINE DECOMPRESSION DISCECTOMY WITH PLANS TO UTILIZE THE MOBI-C ARTIFICIAL CERVICAL DISC REPLACEMENT. AS THE SURGEON ATTEMPTED TO CAREFULLY INTRODUCE THE PROTHESIS, THE UNIVERSAL INSERTER (IMPLANT INSERTER) FAILED, CAUSING THE PROTHESIS TO BE PUSHED PAST THE POSTERIOR WALL OF THE VERTEBRAL BODY AND COMPRESSING THE SPINAL CORD. THE PROTHESIS WAS REMOVED FROM THE DISC SPACE AND A COMPETITIVE INTERBODY CAGE WAS UTILIZED INSTEAD. THE PATIENT IS NOW PARTIALLY PARALYZED. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
IT WAS REPORTED THAT A PATIENT UNDERWENT A C5-C6 ANTERIOR CERVICAL SPINE DECOMPRESSION DISCECTOMY WITH PLANS TO UTILIZE THE MOBI-C ARTIFICIAL CERVICAL DISC REPLACEMENT. AS THE SURGEON ATTEMPTED TO CAREFULLY INTRODUCE THE PROTHESIS, THE UNIVERSAL INSERTER (IMPLANT INSERTER) FAILED, CAUSING THE PROTHESIS TO BE PUSHED PAST THE POSTERIOR WALL OF THE VERTEBRAL BODY AND COMPRESSING THE SPINAL CORD. THE PROTHESIS WAS REMOVED FROM THE DISC SPACE AND A COMPETITIVE INTERBODY CAGE WAS UTILIZED INSTEAD. THE PATIENT IS NOW PARTIALLY PARALYZED. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67636 | MOBI-C IMPLANT M"STANDARD" SIZE UNKNOWN | PROSTHESIS, INTERVERTEBRAL DISC | MJO | LDR MEDICAL | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female | Disability |