MAUDE Adverse Event Report: SYNTHES USA 3.7MM TI CERVICAL SPINE SCREW SLF-TPNG/VARIABLE ANGLE 18MM; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL

Catalog Number 04.647.878

Device Problems Device Operates Differently Than Expected (2913); Difficult to Advance (2920)

Patient Problems Sedation (2368); No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

This device was used for treatment, not diagnosis.No patient information has been provided.(b)(4).Phone number: (b)(6).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.

Event Description

It was reported that during an anterior cervical discectomy and fusion (acdf) procedure at levels c5 to c7, the recess in the head of the screw was too shallow.While using the star drive t8 driver to insert the screws, the star drive t8 driver actually sheared off and burred out of the head of the screw making the screw impossible to insert and/or remove.As a result, the screws could not be locked in fully and could not be advanced.As an alternative, the surgeon used angled drivers rather than straight drivers to complete the procedure but those devices broke.The procedure was delayed by 45 minutes due to this incident.The screws have been implanted in the patient.No pieces from the instrument were left in situ.The patient had suboptimal results for this procedure; there was no harm to the patient reported.This report 4 of 7 for (b)(4).

Manufacturer Narrative

The complainant part has not been explanted.Without a valid lot number, a review of the device history records cannot be requested.The reported event has been determined to represent a product problem only.As such, no patient harm has been assessed for reporting.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.

• Brand Name: 3.7MM TI CERVICAL SPINE SCREW SLF-TPNG/VARIABLE ANGLE 18MM
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL
• 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: 5507525
• MDR Text Key: 40572692
• Report Number: 2520274-2016-11691
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.647.878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1