MAUDE Adverse Event Report: LDR MEDICAL MOBI-C CERVICAL DISC PROSTHESIS

Model Number MB3575

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Review of the initial post op x-rays provided and comments from the surgeon indicate the inferior plate of the artificial disc was positioned slightly posterior.The 2 week post op x-rays show the superior plate migrated at an angle anterior to the inferior plate.After peer review, the surgeon decided to remove and replace the device with another artificial disc, increasing the height and positioning correctly.The explanted device was kept by the patient.Patient retained device.

Event Description

Revision surgery to remove and replace cervical disc arthroplasty device with another larger size.Patient was asymptomatic, but implant inferior plate was positioned too posterior.

• Brand Name: MOBI-C CERVICAL DISC PROSTHESIS
• Type of Device: MOBI-C CERVICAL DISC
• Manufacturer (Section D): LDR MEDICAL; hotel de bureau 1; 4 rue gustave eiffel; rosieres-pres-troyes, 10430 ; FR 10430
• Manufacturer (Section G): MANUFACTURER: LDR MEDICAL REG # 3004788213; hotel de bureau 1; 4 rue gustave eiffel; rosieres-pres-troyes, 10430 ; FR 10430
• Manufacturer Contact: ron musselman ; 13785 research blvd.; #200; austin, TX 78750 ; 5123443333
• MDR Report Key: 5453099
• MDR Text Key: 38745268
• Report Number: 3004903783-2016-00006
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/01/2020
• Device Model Number: MB3575
• Device Lot Number: 5240211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/22/2016
• Device Age: 9 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR