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

Additional narrative: patient initials: (b)(6).Patient weight is unknown.Event date: unknown.This report is for four unknown pangea locking caps/unknown lots.Part and lot numbers are unknown; udi number is unknown.Additional product codes: mni, mnh, kwp, kwq.Implant date: unknown date in 2006.Device was reportedly not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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 that a patient underwent an unknown fusion procedure at the l4-l5 level on an unknown date in 2006.The patient was implanted with synthes pangea screws, rods, and locking caps.On an unknown date, it was determined that there was a non-fusion and instability at the implant level.On (b)(6) 2016, the patient was returned to the operating room where they were implanted with a synthes opal spacer.After implanting the spacer, the surgeon re-attached the rods to the screws, and re-tightened the locking caps; the original devices were not explanted.The surgery was completed successfully.This report is for four unknown pangea locking caps.This is report 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 Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5872626
• MDR Text Key: 51974713
• Report Number: 2520274-2016-14074
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• 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?: No
• Date Manufacturer Received: 07/27/2016
• 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