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

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

Patient Problems Fall (1848); Pain (1994); Non-union Bone Fracture (2369); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: additional patient information: patient height is reported as (b)(6).Exact dates of post-operative events are unknown.This report is for one (1) unknown prodisc-c implant.Without a valid part and lot number, a udi number cannot be generated.It is unknown if the complainant device has been (or will be) explanted.Report the patient¿s pseudoarthrosis.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 via a clinical prodisc-c study that patient (b)(6) underwent an anterior cervical discectomy and fusion (acdf) at c5-c6 on (b)(6) 2003.The patient was discharged on (b)(6) 2003 with a prescription for percocet.It was noted that the patient had a mild onset of clonus beginning (b)(6) 2004.Clonus prior to surgery was absent, but the current state of events is still ongoing.The patient presented with moderate pseudo-arthrosis or nonunion of fusion with right neck/trapezius muscle pain on (b)(6) 2005.The patient was treated with injections of xylocaine 2 and kenalog 1 in the right trapezius muscle and instructed to return for a trigger point injection (ongoing).It was also reported that the patient presented with moderate neck pain radiating into the left trapezius region, with numbness and tingling in the middle finger of the left hand, on (b)(6) 2008.No action was taken, but the event is ongoing.The patient fell on (b)(6) 2010 resulting in trauma to the head.The patient was evaluated in the emergency room; all completed tests came back normal.The patient was discharged to home.The study was completed on (b)(6) 2010.This complaint involves one (1) unknown prodisc-c device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

This report is for an unknown acdf device/unknown lot; part and lot numbers are unknown; udi number is unknown.Alert date was initially reported as 22september2015; afterwards it was discovered a company representative was aware of the event on 07april2008.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 (b)(6) underwent an anterior cervical discectomy and fusion (acdf) at c5-c6 on (b)(6) 2003 with unknown acdf device and was discharged on (b)(6) 2003 with percocet.The study was completed on (b)(6) 2010.The following adverse events were reported: date reported: (b)(6) 2008 event: on (b)(6)2008 (month 48) neuro deterioration - sensory: neck pain radiating into the left trapezius region, with numbness and tingling in the middle finger of left hand.Severity = moderate.Likelihood = unanticipated.Action required = none.Implant involvement = one.Action taken = patient to come in for a trigger point injection.Impairment = neurologic- temporary numbness and tingling.Event related to the surgery = probably.Event related to the implants = possibly.Current state of event = will follow up.The implants were not explanted.This report is for adverse event: date reported: (b)(6) 2008 event: (b)(6) 2008 (month 48) neuro deterioration - sensory: neck pain radiating into the left trapezius region, with numbness and tingling in the middle finger of left hand.Moderate, no action required, no implant involvement.Patient to come back in for a trigger point injections.Investigator comments: probably related to surgery, possibly related to implant.Ongoing.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 (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5144700
• MDR Text Key: 28023924
• Report Number: 2530088-2015-10650
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP070001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 04/07/2008

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/11/2015
• 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
• Patient Weight: 54