MAUDE Adverse Event Report: SYNTHES USA; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

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

Patient Problems Dysphagia/ Odynophagia (1815); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Patient height reported as (b)(6) inches.This report is for an unknown acdf device/unknown lot.Part and lot numbers are unknown; udi number is unknown.It is unknown if the device was explanted.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 clinical prodisc-c study patient id (b)(6) underwent an anterior cervical decompression fusion (acdf) at c5-c6 on (b)(6) 2003.There were no intra-operative complications.Patient was discharged on (b)(6) 2003 and completed the study on (b)(6) 2013.The following events were reported postoperatively: -(b)(6) 2010: stiffness and soreness through cervical spine and upper extremities -(b)(6) 2004: a post-operative wound infection at anterior cervical wound.The patient was treated with irrigation and debridement of wound in the operating room and continued with antibiotics.The patient also experienced difficulty swallowing as a result of the wound infection.-(b)(6) 2005: patient experienced new onset of left hand numbness.Also, intermittent numbness and pain was reported.-(b)(6) 2005: patient experienced progression of original right scapular pain.Pain management will continue.-(b)(6) 2007: patient experienced gradually increasing neck pain over the last year.-month 84 visit on (b)(6) 2010: the patient reported soreness through cervical spine and upper extremities -month 84 visit on (b)(6) 2010: the patient reported numbness and tingling in her upper extremities.This report is for adverse event: (b)(6) 2004: a post-operative wound infection at anterior cervical wound.The patient was treated with irrigation and debridement of wound in the operating room and continued with antibiotics.The patient also experienced difficulty swallowing as a result of the wound infection.Likelihood: unanticipated, severity: severe, implant involvement: deep infection down to hardware, related to surgery: probably, related to implant: unknown, status: ongoing, continuing antibiotics.This report is for an unknown acdf device.This is report 1 of 1 for (b)(4).

• 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: 5289008
• MDR Text Key: 33267381
• Report Number: 2520274-2015-17798
• Device Sequence Number: 1
• Product Code: KWQ
• 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,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• 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: 04/25/2005
• 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
• Patient Weight: 68