MOBI-C IMPLANT M"STANDARD" 15X17 H5
Report
- Report Number
- 3004788213-2022-00050
- Event Type
- Injury
- Date Received
- July 1, 2022
- Date of Event
- June 9, 2022
- Report Date
- October 6, 2022
- Manufacturer
- LDR MÉDICAL
- Product Code
- MJO
- UDI-DI
- 03662663018586
- PMA / PMN Number
- SEE-H10
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS DEVICE IS NOT CLEARED WITHIN THE US. HOWEVER, IT IS SIMILAR TO MB3575, WHICH IS CLEARED UNDER P110009. 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.
CORRECTIONS IN D4: LOT NUMBER AND UDI NUMBER, D9, AND H3. ADDITIONAL INFORMATION IN D4: EXPIRATION DATE AND H4. 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 H3. ADDITIONAL INFORMATION IN H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: THE DEVICE WAS EVALUATED. THE INVESTIGATION FOUND THAT THERE WAS NO IMPINGEMENT ON THE PLATES BUT THERE IS A "NOTCH" ON THE INSERT, CAUSED DURING THE REMOVAL OF THE DEVICE. THERE WAS NO DAMAGE NOTICED IN THE X-RAYS PROVIDED. ROOT CAUSE: THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO TRAUMA, PATIENT FACTORS OR OTHER UNKNOWN OPERATIONAL FACTORS. 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 A REVISION SURGERY WAS PERFORMED TO ADDRESS A MOBI-C IMPLANT THAT WAS SEVERELY KYPHOTIC WITH IMPINGEMENT ON THE ANTERIOR SIDE C6/C7 AFTER THE PATIENT FELL POST-OPERATIVELY. DURING THE REVISION, THE PE CORE WAS FOUND TO BE LOCATED CORRECTLY BETWEEN THE PLATES. IT WAS REMOVED AND REPLACED WITH A NEW MOBI-C IMPLANT.
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS A MOBI-C IMPLANT THAT WAS SEVERELY KYPHOTIC WITH IMPINGEMENT ON THE ANTERIOR SIDE C6/C7 AFTER THE PATIENT FELL POST-OPERATIVELY. DURING THE REVISION, THE PE CORE WAS FOUND TO BE LOCATED CORRECTLY BETWEEN THE PLATES. IT WAS REMOVED AND REPLACED WITH A NEW MOBI-C IMPLANT.
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS A MOBI-C IMPLANT THAT WAS SEVERELY KYPHOTIC WITH IMPINGEMENT ON THE ANTERIOR SIDE C6/C7 AFTER THE PATIENT FELL POST-OPERATIVELY. DURING THE REVISION, THE PE CORE WAS FOUND TO BE LOCATED CORRECTLY BETWEEN THE PLATES. IT WAS REMOVED AND REPLACED WITH A NEW MOBI-C IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1548384 | MOBI-C IMPLANT M"STANDARD" 15X17 H5 | MOBI-C CERVICAL DISC PROSTHESIS | MJO | LDR MÉDICAL | NA | L083377 | 03662663018586 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention| H |