MAUDE Adverse Event Report: SYNTHES (USA); INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Device Problems Failure To Adhere Or Bond (1031); Material Disintegration (1177); Material Fragmentation (1261)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a revision surgery performed on (b)(6) 2014.One of the cortico cancellous anterio cervical fusion(ccacf) spacers(mtf product) which was implanted in (b)(6) 2014 had disintegrated.The collapse caused the disc space to be reduced and the resultant force pushed the vectra plate off the cervical spine thus resulting in its failure also.Failed graft removed, replaced with chronos filled peek cervios cage and a vectra plate with 4 revision screws.Pre-op x-ray taken on (b)(6) is available.Initial surgery was a c2/3 cervical fusion, performed on (b)(6) 2014 where ccacf spacer +vectra plate with 4 screws were implanted.This report is for an unknown ccaf mtf spacer.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

This report is for 1 unknown ccaf mtf spacer.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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information from the device report received by synthes europe from an event in new zealand reported that fragments from the cortico cancellous anterio cervical fusion spacer that reportedly disintegrated were retained in the patient.Additional details are not available.

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The provided x-rays were reviewed: comparing the x-ray of (b)(6) 2014 to that of (b)(6) 2014, there appears to be collapse of graft/disc space at c2-c3.There is one sagittal ct image from (b)(6) 2014, and there is suggestion of change in position of the cranial screw/possibly plate.

• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4386037
• MDR Text Key: 18092379
• Report Number: 2520274-2015-10069
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• 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: 03/27/2015
• 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 Age: 65 YR