MOBI-C IMPLANT "M" STANDARD, UNKNOWN SIZE
Report
- Report Number
- 3004788213-2024-00003
- Event Type
- Injury
- Date Received
- January 19, 2024
- Report Date
- March 6, 2024
- Manufacturer
- LDR MEDICAL
- Product Code
- MJO
- PMA / PMN Number
- P110009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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. JOURNAL ARTICLE: DICESARE, J.A.T., TUCKER, A. M., SAY, I., PATEL, K., LANMAN, T. H., COUFAL, F. J., MILLARD, J., DECKEY, J. E., SHETGERI, S., & MCBRIDE, D. Q. (2020). MECHANICAL FAILURE OF THE MOBI-C IMPLANT FOR ARTIFICIAL CERVICAL DISC REPLACEMENT: REPORT OF 4 CASES. J NEROSURG SPINE, 33, 727-733. HTTPS://THEJNS.ORG/DOI/ABS/10.3171/2020.5.SPINE19442.
H6 ADDITIONAL METHOD CODES: 4109, 4110. ADDITIONAL INFORMATION IN H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: THE PRODUCT WAS NOT RETURNED AND NO PHOTOS WERE PROVIDED, SO AN EVALUATION IS UNABLE TO BE PERFORMED. PRE-OPERATIVE, INTRA-OPERATIVE AND POST-OPERATIVE IMAGES WERE AVAILABLE IN THE ASSOCIATED JOURNAL ARTICLE. SME REVIEW OF THE AVAILABLE INFORMATION AND IMAGES REVEALED THAT PRE-OP RANGE OF MOTION AT C5-C6 WAS SEVERELY LIMITED, WHICH IS CONTRAINDICATIVE FOR MOBI-C CANDIDACY ROOT CAUSE: A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO PATIENT OR SURGERY SPECIFIC FACTORS INCLUDING POOR MOBILITY AT THE OPERATED LEVEL. DHR REVIEW: THE LOT NUMBER WAS NOT PROVIDED, SO THE DHR WAS UNABLE TO BE REVIEWED. 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 WHO HAD UNDERWENT CERVICAL DISC REPLACEMENT WITH A MOBI-C TO TREAT CERVICAL RADICULOPATHY SUBSEQUENTLY DEVELOPED SYMPTOMATIC SEGMENTAL KYPHOSIS, REQUIRING A REVISION SURGERY ONE WEEK POST-OP. THE INITIAL PRESENTATION WAS FOR NECK PAIN AND LEFT ARM PAIN UNRELIEVED W/ PHYSICAL THERAPY AND NERVE BLOCKS; AN MRI SHOWED A HERNIATED DISC AT C5-6, ECCENTRIC TO THE IT. THE INITIAL SURGERY TO CORRECT THIS WAS FOR LEVELS C5-6 AND RESULTED IN A 16 DEGREE SHELL ANGLE AND POST-OPERATIVE SYMPTOMS OF NECK PAIN W/O RADICULOPATHY. THE REVISION SURGERY, AN ANTERIOR CERVICAL FUSION, WAS SUCCESSFULLY PERFORMED ONE WEEK LATER ON C5-6 AND RESOLVED ALL SYMPTOMS.
IT WAS REPORTED THAT A PATIENT WHO HAD UNDERWENT CERVICAL DISC REPLACEMENT WITH A MOBI-C TO TREAT CERVICAL RADICULOPATHY SUBSEQUENTLY DEVELOPED SYMPTOMATIC SEGMENTAL KYPHOSIS, REQUIRING A REVISION SURGERY ONE WEEK POST-OP. THE INITIAL PRESENTATION WAS FOR NECK PAIN AND LEFT ARM PAIN UNRELIEVED W/ PHYSICAL THERAPY AND NERVE BLOCKS; AN MRI SHOWED A HERNIATED DISC AT C5-6, ECCENTRIC TO THE IT. THE INITIAL SURGERY TO CORRECT THIS WAS FOR LEVELS C5-6 AND RESULTED IN A 16 DEGREE SHELL ANGLE AND POST-OPERATIVE SYMPTOMS OF NECK PAIN W/O RADICULOPATHY. THE REVISION SURGERY, AN ANTERIOR CERVICAL FUSION, WAS SUCCESSFULLY PERFORMED ONE WEEK LATER ON C5-6 AND RESOLVED ALL SYMPTOMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2475314 | MOBI-C IMPLANT "M" STANDARD, UNKNOWN SIZE | MOBI-C CERVICAL DISC PROTHESIS | MJO | LDR MEDICAL | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Male | Hospitalization| R |