MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREWS; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Paresis (1998); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Multiple patients involved.Implantation date unknown.This report is for an unknown screws/unknown lot.Part and lot numbers 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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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

Device report from slovakia reports an event as follows: this report is being filed after the review of the following journal article: juricek m., rehak l., rehak j., tisovsky p.,(2010)quality of life after elective lumbar spinal fusions, bratisl lek listy volume 111(5) , pages 290-295 (slovakia) this study aims to evaluate the quality of life after elective lumbar spinal fusions.From 2005 to june 2007 , a total of 208 patients (120 females, 88 males) with mean age of 54.6-9.04 years (range 32-69 years) that underwent an elective stabilization with decompression and fusion for degenerative lumbar spine were included in the study.Patients were treated using the expedium system.The transforaminal lumbar interbody fusion (tlif) with cages leopard and devex was performed in 165 patients, the anterior lumbar interbody fusion (alif) with brantigan cages in 5 patients and the posterolateral lumbar fusion (plf) in 38 patients.Patients were evaluated at 6, 12 and 24 months after surgery.The following complications were reported as follows: after surgery 74 of patients used analgesics sometimes and 68 patients used them daily.A revision surgery was necessary in 18 cases.5 cases of dural sack lesions were a few mm2 and were solved with a simple suture , without a need of further revision.2 deep infection developed, they were managed by an early revision, drainage, and antibiotic therapy.4 superficial infection resolved with antibiotic therapy.2 cases of donor site pain.1 case of breakage of carbon cage occurred during operation-the complication was resolved by an immediate extraction and exchange for a titanium cage.1 case of improper introduction of tlif cage was revised, extracted by anterior approach, and conversed to alif.Most frequent complications were related to instrumentation-17 : improper introduction of screws in 8 patients was dealt with a revision: in 3 patients, a permanent neurological complication occurred- in all cases it was unilateral paresis of lower limbs, no patient had sphincter or sexual disorder.7 broken screws were extracted and replaced.This report is for an unknown depuy spine expedium system, unknown depuy spine leopard, unknown depuy spine devex and unknown depuy spine brantigan cage.This report is for (1) unknown screws this is report 10 of 10 for (b)(4).

• Brand Name: UNKNOWN SCREWS
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL 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 Key: 10836478
• MDR Text Key: 216316458
• Report Number: 1526439-2020-02188
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: LO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• 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
• Date Manufacturer Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention