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 No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient initials are (b)(6).This report is for two (2) unknown pangea rods.Additional product codes for this report include: mni, mnh, kwp, and kwq.(other): without a valid part and lot number, a udi is not available.The original implant procedure was performed on an unknown date in 2012.Per facility, the complainant parts will not be returned for evaluation.(b)(4).Unknown, as specific part and lot numbers for the complainant rods were not provided.Two potential 510k numbers include: k090605 and k082572.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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.

Event Description

It was reported that a patient developed adjacent level disc disease requiring an extension/revision procedure.The patient was originally instrumented with a pangea spine system construct in 2012 at disc levels l4-s1.Due to the adjacent level disc disease, the patient returned to the operating room for revision on (b)(6) 2015.The construct was extended to include disc levels l3-l4.During the procedure, the surgeon left the unknown pangea screws from the original procedure in place at l4-s1.The original two (2) rods, however, were removed and replaced with longer rods.Also, two (2) additional set screws were plated at the l3-l4 level.The revision surgery was completed successfully with no patient harm.This report is for two (2) unknown pangea rods.This report is 2 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 (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5331776
• MDR Text Key: 34566808
• Report Number: 2520274-2015-18116
• 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: Other
• Type of Report: Initial
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2015
• 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
• Patient Outcome(s): Required Intervention