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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN RODS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH UNKNOWN RODS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Neurological Deficit/Dysfunction (1982); Impaired Healing (2378)
Event Type  Injury  
Manufacturer Narrative

Product complaint # (b)(4). Surgical intervention in the form of revision surgery.

 
Manufacturer Narrative

There are multiple patients all information is provided in the article. This report is for an unknown rod/ unknown lot. Part and lot number are unknown; udi number is unknown. 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. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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. (b)(4).

 
Event Description

This report is being filed after the review of the following journal article: baxter g et, al (2014), complications of growing rods used for early onset scoliosis, european spine journal vol. 23 (s1), page s118, (united kingdom). The aim of this study is to identify complications experienced by patients undergoing growing rods surgery for early onset scoliosis (eos) and investigate complication rates between different growing rod implants. A total of 44 patients underwent growing rods surgery for early onset scoliosis. Of these patients, 25 patients were treated with a paediatric isola system and 7 patients were treated with a paediatric expedium. Average follow-up duration was 5 years. The article did not specify which of the devices were being used to capture the following complications: 36 patients had wound complications 3 patients had alignment complications. 6 patients had general complications. 7 patients had neurological complications. 24 patients had implant complications. This report is for a paediatric isola system and a paediatric expedium. This report is for one unknown rod. This is report 1 of 6 for (b)(4).

 
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Brand NameUNKNOWN RODS
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key9473364
MDR Text Key184373554
Report Number1526439-2019-52677
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/16/2019
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 12/16/2019 Patient Sequence Number: 1
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