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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNK - CONSTRUCTS: EXPEDIUM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MEDOS INTERNATIONAL SàRL CH UNK - CONSTRUCTS: EXPEDIUM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559)
Event Type  Injury  
Event Description
This report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) for a total of 230 patients (mean age of 49 years) who were operated with the combination of expedium posterior instrumentation and opal interbody cage between january 02, 2006, and november 22, 2020. The following complications have been identified as per the (b)(6) spine registry ((b)(6)) report: general complications - intraoperative complications: ¿ 6 patients had dural tear. ¿ 1 patient had misplaced implant. General complications ¿ postoperative complications within 1st follow-up year: ¿ 2 patients had deep surgical site infection. ¿ 4 patients had superficial surgical site infection. General complications ¿ reintervention during stay: ¿ 1 patient drain of deep infection. ¿ 1 patient had repair of dural injury. ¿ 1 patient had replacement of implant. Readmission: ¿ 1 patient had adjustment of implant. ¿ 5 patients had drain of deep infection. ¿ 1 patient had drain of hematoma. ¿ 3 patients had refusion. ¿ 5 patients had removal of implant. ¿ 1 patient had repair of dural injury. ¿ 1 patient had readmission to stop bleeding. This is for depuy spine expedium posterior instrumentation. This is report 1 of 3 for (b)(4).
 
Manufacturer Narrative
There are multiple patients. All known information is provided in the literature article. This report is for an unknown expedium construct/unknown lot. Part and lot number are unknown; udi number is unknown. There are multiple unknown dates of implantation between january 02, 2006 and november 22 2020. 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.
 
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Brand NameUNK - CONSTRUCTS: EXPEDIUM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
MDR Report Key12633183
MDR Text Key281671647
Report Number1526439-2021-02168
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,study
Type of Report Initial
Report Date 09/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2021
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 10/14/2021 Patient Sequence Number: 1
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