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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN PLATES PLATE, FIXATION, BONE

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MEDOS INTERNATIONAL SàRL CH UNKNOWN PLATES PLATE, FIXATION, BONE Back to Search Results
Catalog Number UNK PLATES
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Injury (2348); Spinal Cord Injury (2432); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
There are multiple patients. All known information is provided in the literature article. 510k: this report is for an unknown plates/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. (b)(4). 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 the following article, 'evaluation of healthcare outcomes of patients implanted with the depuy synthes synmesh vertebral body replacement system during corpectomy procedures of the cervical, thoracic, and lumbar spine: a real-world evidence external registry review, british spine registry', vol xxxx, pages 1-22 (united kingdom). This retrospective study aims to describe patients implanted with the synmesh vertebral body replacement (vbr) device using a national spine registry database. Between july 1, 2011 and august 31, 2019, a total of 25 patients (11 females, 14 males) with mean age of 64 years were identified with synmesh in the text fields in the bsr registry database. All patients in the study population underwent anterior corpectomy procedures using the depuy synthes synmesh device. Twenty-one (21) patients had an anterior-only approach, while 4 patients had a combination of an anterior approach, and posterior supplemental fixation. Supplemental fixation was noted in eighteen patients. Among patients with supplemental fixation, fourteen patients had anterior plate fixation. Both the depuy synthes skyline plate (n
=
1) and cervical spine locking plate¿cslp (n
=
1) were identified among these patients. Four (4) patients who had a combination of an anterior corpectomy and a posterior stabilization procedure received either lateral mass or pedicle screw supplemental fixation. The posterior stabilization systems identified in this cohort included expedium posterior (n
=
1), universal spine system¿uss 2 (n
=
1), and uss 2 with the synapse system (n
=
1). One of the four patients who had a combined anterior-posterior approach had both anterior screw and rod fixation and posterior supplemental pedicle screw fixation [aouss¿depuy synthes]. Patients were followed-up to five years postoperatively. The following complications were reported: the following complications were noted in three of the patients diagnosed with tumor: dural tear (n
=
1), left common iliac vein laceration (n
=
1), and pelvic ureteric junction (puj) obstruction (n
=
1). These three patients did not have a re-operation, or revision. The complication which the fourth patient (4% of the total cohort) experienced was not reported. This patient underwent a revision of the surgical site with removal of hardware three months postoperatively. No further details surrounding this event were listed. No other patient had a revision procedure. Three patients (43%) who experienced complications had degenerative disease diagnoses. The following complications were noted in these three patients: dysphonia (n
=
1), peripheral neuropraxia (n
=
1), and spinal cord injury (n
=
1). The two patients (8% of the total cohort) who sustained the latter two complications required reoperation, but no revision involving implant removal from the surgical site. The two patients who experienced dysphonia and spinal cord injury had two-level corpectomy procedures. The patient who experienced peripheral neuropraxia had a single-level corpectomy. Among all the patients diagnosed with tumor or trauma per the ifu, one patient with a tumor diagnosis had revision of the surgical site, and no other patient had a reoperation or revision. This patient had a thoracic or lumbar corpectomy procedure. No further details were provided regarding the patient¿s procedure. A patient diagnosed with deformity had a reduction in back pain at 12 months after the index procedure; however, the patient had an increase in leg pain. This report is for an unknown depuy spine skyline plate, unknown depuy spine expedium posterior. This is report 1 of 3 for (b)(4).
 
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Brand NameUNKNOWN PLATES
Type of DevicePLATE, FIXATION, BONE
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
SZ
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key10521874
MDR Text Key214305140
Report Number1526439-2020-01640
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK PLATES
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 Received08/17/2020
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: 09/11/2020 Patient Sequence Number: 1
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