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

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

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994); Weakness (2145); Disability (2371)

Event Type  Injury  

Manufacturer Narrative

Subject was included in the randomized control group; synthes is unable to precisely determine the manufacturer of their spine system implants.There were four (4) pedicle systems that were identified and approved in the study protocol for use as the control; however, no synthes manufactured products were referenced.Synthes did market a pedicle system at the time and the surgeon could have utilized this product.(b)(6).This report is for an unknown spine pedicle system/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 (b)(6) clinical study patient id (b)(6) was implanted with an unknown spine pedicle system at l4-5, l5-s1.Subject (b)(6) had a history of degenerative disc disease at l4-5, l5-s1.The patient was enrolled in the (b)(6) study and was randomized to the control group.The patient underwent anterior lumbar interbody fusion at levels l4-5, l5-s1 on (b)(6) 2003.The patient was evaluated postoperatively at 3 months and 24 months.The patient was non-compliant with the protocol and missed the following post-operative visits: 6 weeks, 6 months, 12 months and 18 months.Following the 24 months visit, the patient developed progression right sided leg pain, weakness and decreased sensation.The patient underwent hardware removal and right foraminotomy on (b)(6) 2006.Postoperatively, the patient was neurologically intact with some decreased sensation in the lower medical foot as he had preoperatively.The ae-crf form reports: likelihood of event was anticipated.Severity of event was severe - incapacitating, unable to perform, interfere with daily activities.Action required was hospitalization with surgery.Implant involvement was none.Course of action taken: on (b)(6) 2006, patient underwent l4-s1 hardware removal with revision decompression; right l4-l5.Subject had pain management consult.Impairment was reported as none.Investigator reported the event was definitely related to the type of surgery.Investigator reported the event was definitely not related to the implants.Current state of event was reportedly resolved.This report is for an unknown spine pedicle system.This is report 1 of 1 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5336695
• MDR Text Key: 34742479
• Report Number: 2520274-2015-18139
• 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: 02/01/2007

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• 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: 02/01/2007
• 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 Age: 56 YR