MAUDE Adverse Event Report: SYNTHES (USA) 4.0MM TI CERV SELF-RETAIN SCR SLF-TPNG/FIXED ANGLE 16MM; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Catalog Number 04.613.816

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Discomfort (2330)

Event Type  Injury  

Event Description

Implanted at c3-c5 with a vectra plate and four screws.The vertebrae c3 to c5 were not lined up and the patient subluxed over.It was reported that postoperatively the plate backed-out and on (b)(6) 2014 all the hardware was removed.The surgeon was unable to perform the scheduled revision due to the patient experiencing a low white blood cell count suspected to be cause by an infection.The surgeon plans to stabilize the patient posteriorly after the patient recovers from the infection.It was reported the patient had pain, irritation and discomfort.An image reading of the x-rays was conducted by a medical director from this manufacturer.The review reported: pre-operative image, sagittal view shows cervical spine vertebrae c3 to c6 are not neatly lined, physical curve disappeared, a possible subluxation at c3/4 level, some levels have very narrow intervertebral disc space.The shape and size of c3-5 are abnormal compare to other vertebrae.(look like dish disease, but it¿s difficult to determine without knowing the patient history) ap (anterior posterior) and lateral x-rays prior to removal of construct show anterior cervical plate spans from c3-c5 with two screws at c3 and two at c5.At least one upper screw (c3) appears backed-out from the c3 and plate.Ap view shows the long axis of the plate is not parallel to the cervical spine axis.C3 to c5 vertebrae are not lined.This is report 5 of 5 for com-(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.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.

• Brand Name: 4.0MM TI CERV SELF-RETAIN SCR SLF-TPNG/FIXED ANGLE 16MM
• Type of Device: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• 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: 4075874
• MDR Text Key: 4855086
• Report Number: 2520274-2014-13519
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK071667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.613.816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2014
• 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: 64