MAUDE Adverse Event Report: SYNTHES USA 4.0MM TI CORTEX EXPANSIONHEAD SCREW SELF-DRILLING 14MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 450.138

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Screw loosing occurred between (b)(6 )2015.(b)(4).It was noted the device was discarded by the hospital.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

It was reported the patient underwent an anterior cervical discectomy and fusion (acdf) surgery on (b)(6) 2015 and was implanted with a cervical spine locking plate (cslp) construct, level c4-c6.The patient returned to the operating room on (b)(6) 2015 for revision surgery to replace two loose cslp locking plate screws at level c4.The revision was successfully completed.The patient outcome was fine.This is report 1 of 2 for (b)(4).

• Brand Name: 4.0MM TI CORTEX EXPANSIONHEAD SCREW SELF-DRILLING 14MM
• 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: 5242649
• MDR Text Key: 31822963
• Report Number: 2520274-2015-17458
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK031276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 450.138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2015
• 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
• Treatment: UNKNOWN CERVICAL SPINE LOCKING PLATE
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR