MAUDE Adverse Event Report: SYNTHES BRANDYWINE; PROSTHESIS, INTERVERTEBRAL DISC

Device Problems Failure To Adhere Or Bond (1031); Unintended Movement (3026)

Patient Problems Pain (1994); Discomfort (2330); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the superior endplate of a prodisc-c implant has not had any sort of bony attachment on the c5 endplate and the keel cut in the c5 vertebral body is no longer clean- there appears to be a halo around the keel of the prodisc-c implant so it is not anchored very well.It was reported that the patient was implanted with a prodisc-c at c5-c6 on (b)(6) 2014.The surgeon reported that the patient did very well.The surgeon saw the patient in clinic on (b)(6) 2015 and the patient commented that it felt like her hands were twice their normal size, had arm pain, and some numbness in her right hand.The patient told the surgeon that she has had the symptoms for two months and they have progressively gotten worse.Based on the images taken in clinic on (b)(6) 2015, the surgeon commented that the superior endplate of the prodisc-c does not appear to have had any sort of bony attachment onto the c5 endplate.The surgeon also said that the keel cut in the c5 vertebral body is no longer clean and it appears that there is a halo around the keel of the prodisc-c implant so it is not anchored very well (view ap image).As a result the prodisc-c superior endplate seems to have moved anterior from its original position.The surgeon and the patient have discussed potentially removing the device and having an acdf at the c5-c6 level.No revision date is scheduled.X-ray images provided to synthes were reviewed by the synthes medical director on (b)(4) 2015.The review stated that the prodisc-c is implanted at c5/6 level.But by comparing several images taken on (b)(6) 2015 with one lateral image dated on (b)(6) 2014, it is difficult to confirm what was described in the complaint, such as ¿halo around the keel¿.The superior prodisc-c endplate seems moved anteriorly slightly.Cervical spine ct may be useful for further diagnosis.This report is for one unknown prodisc-c implant.This is report 1 of 1 (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for one unknown prodisc-c implant.Part and lot number were not provided by reporter.Udi is unknown.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4631405
• MDR Text Key: 5615721
• Report Number: 2530088-2015-10091
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP070001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 55