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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH CONF PERIMETER MESH KIT; POLYMETHYLMETHACRYLATE BONE CEMENT
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MEDOS INTERNATIONAL SàRL CH CONF PERIMETER MESH KIT; POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Catalog Number 283922000
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/21/2021
Event Type  Injury  
Manufacturer Narrative
Additional narrative: reporter is a j&j employee.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during a spinal surgery, the pedicle of the cannula broke off and remained in the patient between the vertebra.The surgeon left the piece in the patient and closed the wound.There is no further information available.This report is for one (1) conf perimeter mesh kit.This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: g4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h4, h6: a review of the receiving inspection (ri) for conf perimeter mesh kit was conducted identifying that lot number: 5308779 was released in a single batch.Batch1: released on june 05, 2020 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Visual inspection: the cannula+stylet needle assembly was received at us customer quality (cq).Visual inspection of the device showed the drill protective sleeve had broken off.The stylet molded assembly was missing.Also, foreign substances were observed on the body.However, the reported condition for embedded device was not confirmed since no x-ray images were provided.No other issues were observed with the complaint device.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.No design issues or discrepancies were identified.Investigation conclusion: the overall complaint was confirmed as the needle had broken off, and the polycarbonate cap was missing.The reported condition for embedded device was not confirmed.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d4 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 Name
CONF PERIMETER MESH KIT
Type of Device
POLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ  02400
MDR Report Key12198154
MDR Text Key262556266
Report Number1526439-2021-01440
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 06/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number283922000
Device Lot Number5308779
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2021
Date Manufacturer Received08/17/2021
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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