MOBI-C IMPLANT M"STANDARD" 13X17 H6
Report
- Report Number
- 3004788213-2024-00041
- Event Type
- Injury
- Date Received
- May 30, 2024
- Report Date
- February 10, 2026
- Manufacturer
- LDR MEDICAL
- Product Code
- MJO
- UDI-DI
- 03662663018395
- PMA / PMN Number
- SEEH10
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTIONS IN D9 AND H3. ADDITIONAL INFORMATION IN H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. INSPECTION THE RETURNED DEVICE MATCHES THE INFORMATION IN THE COMPLAINT FILE AND WAS EXAMINED. VISUAL INSPECTION REVEALED THE POLYETHYLENE INSERT IS FRACTURED. SEE ATTACHED IMAGES. DHR REVIEW THE DHR WAS REVIEWED. THERE ARE NO INDICATIONS OF MANUFACTURING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT AND THE DEVICE WAS LIKELY CONFORMING WHEN IT LEFT HIGHRIDGE¿S CONTROL. POTENTIAL 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. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SENT.
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.
CORRECTIONS IN D1 AND D4: CATALOG & LOT NUMBER. ADDITIONAL INFORMATION IN D4: EXPIRATION DATE & UDI NUMBER, AND H4. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT, 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 A PHOTO WAS PROVIDED WHICH SHOWS THAT THE POLY CORE HAS FRACTURED. 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 LOT NUMBER WAS NOT REPORTED AND THE DEVICE WAS NOT RETURNED, THEREFORE A DHR REVIEW IS UNABLE TO BE PERFORMED. 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 MOBI-C REVISION SURGERY WAS PERFORMED ROUGHLY FOUR YEARS AFTER THE INITIAL SURGERY TO REMOVE THE POLYETHYLENE ELEMENT DUE TO PROLAPSE AND PRESSURE ON THE PATIENT'S SPINAL CORD. FURTHER PATIENT INFORMATION IS UNAVAILABLE AT THIS TIME.
IT WAS REPORTED THAT A MOBI-C REVISION SURGERY WAS PERFORMED ROUGHLY FOUR YEARS AFTER THE INITIAL SURGERY TO REMOVE THE POLYETHYLENE ELEMENT DUE TO PROLAPSE AND PRESSURE ON THE PATIENT'S SPINAL CORD. FURTHER PATIENT INFORMATION IS UNAVAILABLE AT THIS TIME.
IT WAS REPORTED THAT A MOBI-C REVISION SURGERY WAS PERFORMED ROUGHLY FOUR YEARS AFTER THE INITIAL SURGERY TO REMOVE THE POLYETHYLENE ELEMENT DUE TO PROLAPSE AND PRESSURE ON THE PATIENT'S SPINAL CORD. FURTHER PATIENT INFORMATION IS UNAVAILABLE AT THIS TIME.
IT WAS REPORTED THAT A MOBI-C REVISION SURGERY WAS PERFORMED ROUGHLY FOUR YEARS AFTER THE INITIAL SURGERY TO REMOVE THE POLYETHYLENE ELEMENT DUE TO PROLAPSE AND PRESSURE ON THE PATIENT'S SPINAL CORD. FURTHER PATIENT INFORMATION IS UNAVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1580764 | MOBI-C IMPLANT M"STANDARD" 13X17 H6 | MOBI-C CERVICAL DISC PROTHESIS | MJO | LDR MEDICAL | NA | L082335 | 03662663018395 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Female | Hospitalization| R |