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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES BRANDYWINE; PROSTHESIS INTERVERTEBRAL DISC
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SYNTHES BRANDYWINE; PROSTHESIS INTERVERTEBRAL DISC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burning Sensation (2146); Numbness (2415)
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.This report is for an unknown 5mm prodisc c implant.Unknown part number, udi is unavailable.It is unknown if the device has been 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 presented continued issues with sympathetic nerve dystrophy causing numbness in hands and burning on chest.The medium 5mm prodisc-c was implanted at the c6-c7 level with no reported complications.This report is for an unknown 5mm prodisc c implant.This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Event date: the date of symptom onset is unknown; however, the patient reported the events during a follow up visit on (b)(6) 2009.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.
 
Manufacturer Narrative
The initial complaint was reviewed and found not reportable.There is no allegation of a complaint against this device, there is no reported malfunction.There is no indication that this device may have caused or contributed to the reported adverse event.There is no information regarding the severity of the symptoms for these events, or whether or not there was any treatment for the events.There is no information to suggest a clear association between the reported events and the device.In the absence of further information, this is not considered a reportable event.If additional information becomes available, this determination should be re-reviewed by a clinician.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
The initial complaint was reviewed and found not reportable.There is no allegation of a complaint against this device, there is no reported malfunction.There is no indication that this device may have caused or contributed to the reported adverse event.There is no information regarding the severity of the symptoms for these events, or whether or not there was any treatment for the events.There is no information to suggest a clear association between the reported events and the device.In the absence of further information, this is not considered a reportable event.If additional information becomes available, this determination should be re-reviewed by a clinician.
 
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Type of Device
PROSTHESIS INTERVERTEBRAL DISC
Manufacturer (Section D)
SYNTHES BRANDYWINE
1303 goshen parkway
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 Key5134709
MDR Text Key27779609
Report Number2530088-2015-10641
Device Sequence Number1
Product Code MJO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PP070001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,study
Reporter Occupation Other
Type of Report Followup,Followup
Report Date 09/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2015
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 Received12/02/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight68
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