MAUDE Adverse Event Report: SYNTHES USA TI VECTRA(TM) PLATE 1 LEVEL/14MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 04.613.014

Device Problems Break (1069); Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a patient underwent an anterior cervical decompression fusion c4-5 procedure in which a drill tap screw (dts) guide was seated into the vectra plate and used throughout the procedure.A 14mm drill was used through the dts guide creating a pathway for a 4mm self-tapping fixed angle screw.The screw was inserted through the dts guide, but it would not advance beyond the elgiloy clip, which is the locking mechanism for the plate.A 4.5mm self-tapping fixed angle rescue screw was then used, but it would not advance below the elgiloy clip either.That screw was then removed and the surgeon noticed that the elgiloy clip had broken and dislodged from the plate.The clip was removed and the surgeon chose to put the 4.5mm screw back in without the clip.The remaining screws went in to the plate without issue and seated below the clips as they should.A surgical delay of 5 minutes was noted.No patient harm reported.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Patient was born on an unknown day in 1949.Device was not implanted/explanted.Device is expected to be returned to the manufacturer for review/investigation.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number was provided.Device 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

Additional narrative: manufacturing evaluation: the investigation of the returned elgiloy clip has shown that the clip is indeed badly deformed / bent.It is likely that the screws may have not been inserted accordingly (on an angle) just enough to rip the clip out of its position.The surgeon indicated that he has used the screw without the dislodged clip, without issues.Therefore, we were not able to inspect the plate as such.Based on these findings we conclude that excessive mechanical force or possibly inappropriate use may have resulted in the damage of the clip.Device 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

(b)(4): the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

It was reported the patient had a traumatic injury to the cervical spine from a four wheel motorcycle accident resulting in a complete cord injury and with the patient being a quadriplegic.The c4/5 anterior cervical decompression fusion (acdf) was performed to stabilize the cervical spine.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient's age at time of the event is unknown.Only patient's year of birth, 1949, was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI VECTRA(TM) PLATE 1 LEVEL/14MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4402113
• MDR Text Key: 18929516
• Report Number: 2520274-2015-10195
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK050451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.613.014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 63