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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE 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 viper implants/ unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. Reporter is a j&j 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

Device report from depuy spine reports an event in (b)(6) as follows: this report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra) to compare usage and outcomes recorded for viper implants in 149 patients (150 procedures) against all other surgical cases recorded within the spine tango registry between 2004 and april 19, 2021. There were 60 males and 90 females with a mean age of 63. 1 years. Final registry report outcome description: general complications- intraoperative none. General complications- postoperative surgical before discharge 3 patients had cardiovascular complications. 1 patient had pulmonary complications. 2 patients had cerebral complications. 5 patients had kidney or urinary complications. 2 patients had liver or gastrointestinal complications. 2 patients had thromboembolism. 4 patients had other complications. 3 patients had complications that were not documented. Surgical complications- intraoperative adverse events 2 patients had nerve root damage. 14 patients had dural lesion. 2 patients had other intraop adverse events. Surgical complications- postoperative surgical before discharge 1 patient had epidural hematoma. 1 patient had other hematoma. 1 patient had radiculopathy. 1 patient had csf leak or pseudomeningocele. 2 patients had motor dysfunction. 2 patients had sensory dysfunction. 2 patients had wound deep infection. 3 patients had implant malposition 1 patient had implant failure. 3 patients had other postoperative surgical complications. 3 patients had postoperative surgical complications that were not documented. Reoperations: 17 reoperations at any level at 1 year after surgery. 5 reoperations at any level at 2 years after surgery. 8 reoperations at any level 1 year after surgery. 1 reoperation at any level 2 years after surgery. This is for depuy spine viper implants. This report captures reported events of dural lesion and other intraop adverse events. This is report 1 of 3 for (b)(4).

 
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Brand NameUNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
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 (Section G)
MEDOS INT SPINE
chemin blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key11890526
MDR Text Key262642219
Report Number1526439-2021-01042
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 04/29/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/26/2021
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2021
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: 05/26/2021 Patient Sequence Number: 1
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