MAUDE Adverse Event Report: SYNTHES (USA); ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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

Patient Problem Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information is not available for reporting.Date of event: date unknown.Additional device product code are: mni, mnh, kwp, kwq.This report is for 3 unknown locking caps.Part and lot numbers were not provided by reporter.Udi: unknown part number, udi is unavailable.Implant date unknown.The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(4).This report is for 3 unknown locking caps.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.

Event Description

It was reported that patient had a revision surgery on (b)(6) 2016 for removal of pangea implants.The reason for the revision surgery is unknown.Patient was originally implanted on an unknown date and unknown reason in the left pedicle at l4-s1 disc space with posterior pedicle screws and rod fixation.The surgeon removed one rod, three screw and three locking caps.It was observed that the removed implants had no issues.It is unknown what the patient was revised to.Patient status/outcome is unknown.Procedure was successfully completed with no surgical delay.This report is for 3 unknown locking caps.This report is 1 of 3 for (b)(4).

• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5942901
• MDR Text Key: 54435382
• Report Number: 2520274-2016-14485
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2016
• 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