MAUDE Adverse Event Report: SYNTHES USA 3.7MM TI CERVICAL SPINE SCREW

Catalog Number 04.647.876

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the patient was implanted on unknown date in (b)(6) 2013 with a zero-p construct at c3-c4 levels.Approximately 2 months post-operatively, during the follow up visit, it was discovered that the cranial-oriented screw of the construct had backed out.The patient was returned to the operating room on (b)(6) 2014 for removal of the zero-p variable angle construct and two unknown loose screws.The implant was not replaced by any other hardware and the procedure was successfully completed.This is report 1 of 2 for file (b)(4).This report is for 1 of 2 unknown screws that were removed.

Manufacturer Narrative

This device is intended for treatment, not diagnosis.(b)(6).This report is for 1 of 2 unknown screws.Implant date: (b)(6) 2013.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn.Placeholder.

Manufacturer Narrative

Implant date: (b)(6) 2013; exact date unknown.Device history record review: review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.

Manufacturer Narrative

Device is used for treatment not diagnosis.This previously reported unknown screw for quantity of 2ea has been identified as item 04.647.876 3.5mm ti cervical spine screw self tapping variable angle 16mm -quantity of 1ea.An additional medwatch was submitted for the other unknown screw.

Event Description

This previously reported unknown screw for quantity of 2 ea has been identified as item 04.647.876 3.5mm ti cervical spine screw self tapping variable angle 16mm -quantity of 1ea.An additional medwatch will be sent for the other unknown screw on (b)(4).This report is for 1 of 3 for (b)(4).

Manufacturer Narrative

According to the additional evaluation, the device showed heavy wear and tear on the outside thread.The torx is damaged.The anodized color is worn out.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.We can only assume that the screw was not inserted aligned into the counterpart and during the screwing procedure there were applied high mechanical forces on the screw head which could cause the complained issue.Because of the damage, the complaint relevant dimensions cannot be checked for dimensional accuracy.Therefore this complaint is to be indeterminate from a manufacturing standpoint.

Manufacturer Narrative

Product development event evaluation: one zero-p va spacer and plate was returned with two cervical spine screws for the cranially oriented screw reportedly backing out post-operatively.The zero-p implant is designed to not extend beyond the confines of the intervertebral space midline, limiting risk of contact with vessels and adjacent soft tissue.Additionally the implant allows for variable angle screw insertion and a securing mechanism to prevent screw back-out (technique guide j9912-d).The product drawings were reviewed during the investigation.The plate is designed for the screw head to pass beyond the securing mechanism.This locks the screw in place and reduces the risk of screw back-out.An important note is included in the technique guide to use intraoperative imaging to verify the screws have been properly positioned.The mechanism of the returned plate was tested with the returned screws and found to work as intended.The screws passed beyond the catch of the mechanism without difficulty and could not back-out from the plate.The screws could not be separated from the plate without an instrument to press the catch toward the plate¿s midline.After testing of the returned implants, it is reasonable to suggest that the screw back out is a result of the screw not being fully inserted into the plate and beyond the securing mechanism.In conclusion, the securing mechanism on the plate, designed to help prevent screw back-out, was tested.The mechanism locked the screws to the plate and they could not dissociate without an instrument to press the mechanism toward the plate¿s midline.Evidence suggests that the screw may not have been fully inserted through the plate however this cannot be confirmed.The complaint is therefore indeterminate from a design perspective.

• Brand Name: 3.7MM TI CERVICAL SPINE SCREW
• Manufacturer (Section D): SYNTHES USA; west chester PA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3591000
• MDR Text Key: 4163362
• Report Number: 2520274-2014-00250
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.647.876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2014
• Initial Date FDA Received: 01/24/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/17/2014; 04/30/2014; 08/05/2014; 09/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2012
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 73