MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Device Problem No Apparent Adverse Event (3189)

Patient Problems Hypersensitivity/Allergic reaction (1907); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/rod construct accessories/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.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

It was reported that on an unknown date, surgeon needed a list of every metal that is in this hardware due to a patient that had an apparent allergy to several of her implants and would like to be tested for said metals.Procedure and patient outcome are unknown.This report is for one (1) unknown screw/rod construct accessories.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

• Brand Name: UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9460792
• MDR Text Key: 187238890
• Report Number: 1526439-2019-52670
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention