MOBI-C IMPLANT M"STANDARD" 17X17 H5
Report
- Report Number
- 3004788213-2022-00122
- Event Type
- Malfunction
- Date Received
- December 5, 2022
- Date of Event
- November 10, 2022
- Report Date
- May 31, 2023
- Manufacturer
- LDR MÉDICAL
- Product Code
- MJO
- UDI-DI
- 03662663018784
- PMA / PMN Number
- SEE-H10
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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. 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 3004788213-2022-00121.
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.
CORRECTIONS IN D4: UDI NUMBER AND H3. ADDITIONAL INFORMATION IN H4 AND H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: VISUAL INSPECTION REVEALED NO SIGNS OF DAMAGE. A FUNCTIONAL INSPECTION WAS PERFORMED BY ATTACHING THE IMPLANTS TO AN INSERTER AND INSERTING THEM INTO A CERVICAL SAW BONE. THE IMPLANTS WERE ABLE TO BE INSERTED AS EXPECTED. X-RAYS WERE PROVIDED, WHICH SHOW THAT THE INFERIOR VERTEBRA APPEARS TO BE PUSHED/MOVED POSTERIORLY. THE INFERIOR ENDPLATE IS ALSO NOT SITTING FLUSH ON THE VERTEBRAL BODY, WHICH MAY BE A RESULT OF THE DISC SPACE NOT BEING COMPLETELY CLEARED OUT. ROOT CAUSE: A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO THE DISC SPACE NOT BEING COMPLETELY CLEARED OUT DURING THE SURGERY OR INSUFFICIENT DISTRACTION. DHR REVIEW: PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMVIE CONTROL. 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 WHILE INSTALLING A MOBI-C IMPLANT INTO THE DISC SPACE, THE LOWER PART OF THE BONE TILTED AWAY. THE IMPLANT WAS REMOVED AND REPLACED WITH A SMALLER IMPLANT, BUT THE SECOND IMPLANT WOULD NOT GO INTO THE DISC SPACE, EITHER. THE SECOND IMPLANT WAS ALSO REMOVED AND THEN A CAGE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT IMPACTS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
WHILE INSTALLING A MOBI-C IMPLANT INTO THE DISC SPACE, THE LOWER ART OF THE BONE TILTED AWAY. THE IMPLANT WAS REMOVED AND REPLACED WITH A SMALLER IMPLANT, BUT THE SECOND IMPLANT WOULD NOT GO INTO THE DISC SPACE, EITHER. THE SECOND IMPLANT WAS ALSO REMOVED AND THEN A THIRD PARTY CAGE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS ABOUT A 1 1/2 HOUR DELAY BUT NO PATIENT IMPACTS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
WHILE INSTALLING A MOBI-C IMPLANT INTO THE DISC SPACE, THE LOWER ART OF THE BONE TILTED AWAY. THE IMPLANT WAS REMOVED AND REPLACED WITH A SMALLER IMPLANT, BUT THE SECOND IMPLANT WOULD NOT GO INTO THE DISC SPACE, EITHER. THE SECOND IMPLANT WAS ALSO REMOVED AND THEN A THIRD PARTY CAGE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS ABOUT A 1 1/2 HOUR DELAY BUT NO PATIENT IMPACTS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2541534 | MOBI-C IMPLANT M"STANDARD" 17X17 H5 | MOBI-C CERVICAL DISC PROSTHESIS | MJO | LDR MÉDICAL | NA | L083127 | 03662663018784 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |