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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN MONO/POLYAXIAL SCREWS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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MEDOS INTERNATIONAL SàRL CH UNKNOWN MONO/POLYAXIAL SCREWS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative

This report is for an unknown mono/polyaxial screw/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a synthes employee. 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.

 
Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing discectomy and fusion. Failed discectomy and fusion has been identified as the reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: intraop general complications: 1 patient had anasthesiological complications. 1 patient had other complications. 1 patient had complications that were not documented. Surgical complications: intraop adverse events: 18 patients had dural lesions. 3 patients had other complications. Postop general before discharge: 2 patients had cardiovascular complications. 4 patients had pulmonary complications. 3 patients had kidney/urinary complications. 2 patients had liver/gi complications. 1 patient had thromboembolism complications. 2 patients had other complications. Surgical complications: postop surgical before discharge: 1 patient had epidural hematoma. 4 patients had other hematoma. 3 patients had radiculopathy. 3 patients had csf leak / pseudomeningocele. 5 patients had motor dysfunction. 2 patients had sensory dysfunction. 2 patients had bowel / bladder dysfunction. 2 patients had wound infection deep. 2 patients had other complications. 1 patient had implant failure. Reoperations: 35 patients had reoperations at 1 year. 4 patients had reoperations at 2 years. 1 patient had a reoperation at 3 years. 1 patient had a reoperation at 4 years. Surgical complications: postop surgical before discharge: 5 patients had implant malposition. This report is for an expedium. This report is for one (1) unknown mono/polyaxial screw. This is report 2 of 3 for (b)(4).

 
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Brand NameUNKNOWN MONO/POLYAXIAL SCREWS
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
MEDOS INT SPINE
chemin blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
chemin blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key12303507
MDR Text Key266668398
Report Number1526439-2021-01657
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,OTHER
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 04/23/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/10/2021
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 Received04/23/2021
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: 08/10/2021 Patient Sequence Number: 1
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