MOBI-C IMPLANT M"STANDARD", UNKNOWN SIZE
Report
- Report Number
- 3004788213-2023-00040
- Event Type
- Injury
- Date Received
- May 5, 2023
- Report Date
- June 12, 2024
- Manufacturer
- LDR MÉDICAL
- Product Code
- MJO
- PMA / PMN Number
- SEE H10
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- 003
Narratives
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.
ADDITIONAL INFORMATION IN H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED, HOWEVER X-RAY IMAGES WERE PROVIDED WHICH SHOW THAT THE IMPLANT PLATES HAD MIGRATED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO UNKNOWN SURGICAL OR PATIENT 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 VISITED THE EMERGENCY ROOM WITH SEVERE UPPER BACK PAIN AND ACUTE PARAPLEGIA. EMERGENT SURGICAL EXPLORATION WAS PERFORMED DUE TO THE ACUTE ONSET OF PARAPLEGIA. DURING THE PROCEDURE, THE PLATES OF THE PROSTHESIS HAD SUBSIDED INTO THE UPPER AND LOWER VERTEBRA, BUT REMOVAL OF BOTH PLATES WAS POSSIBLE AFTER DRILLING THE JUNCTION. POSTERIOR HERNIATION OF THE NUCLEUS WAS DETECTED. T1 CORPECTOMY WAS PERFORMED TO REMOVE THE NUCLEUS OF THE PROSTHESIS COMPLETELY AND SAFELY. A TITANIUM MESH CAGE FILLED WITH AUTOLOGOUS BONE WAS IMPLANTED AND FIXED USING A VENTRAL PLATE. THE PATIENT UNDERWENT PHYSICAL THERAPY AND OCCUPATIONAL THERAPY FOLLOWING THE EMERGENT OPERATION. ONE MONTH AFTER SURGERY, THE PATIENT COULD WALK WITHOUT ASSISTANCE.
IT WAS REPORTED THAT A PATIENT VISITED THE EMERGENCY ROOM WITH SEVERE UPPER BACK PAIN AND ACUTE PARAPLEGIA. EMERGENT SURGICAL EXPLORATION WAS PERFORMED DUE TO THE ACUTE ONSET OF PARAPLEGIA. DURING THE PROCEDURE, THE PLATES OF THE PROSTHESIS HAD SUBSIDED INTO THE UPPER AND LOWER VERTEBRA, BUT REMOVAL OF BOTH PLATES WAS POSSIBLE AFTER DRILLING THE JUNCTION. POSTERIOR HERNIATION OF THE NUCLEUS WAS DETECTED. T1 CORPECTOMY WAS PERFORMED TO REMOVE THE NUCLEUS OF THE PROSTHESIS COMPLETELY AND SAFELY. A TITANIUM MESH CAGE FILLED WITH AUTOLOGOUS BONE WAS IMPLANTED AND FIXED USING A VENTRAL PLATE. THE PATIENT UNDERWENT PHYSICAL THERAPY AND OCCUPATIONAL THERAPY FOLLOWING THE EMERGENT OPERATION. ONE MONTH AFTER SURGERY, THE PATIENT COULD WALK WITHOUT ASSISTANCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 474222 | MOBI-C IMPLANT M"STANDARD", UNKNOWN SIZE | MOBI-C CERVICAL DISC PROSTHESIS | MJO | LDR MÉDICAL | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Prefer Not To Disclose | Hospitalization| R |