MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN RODS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Dc: reported device failure without specific identification of failure.(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is filed after subsequent review of literature article: posterior stabilization strategies following resection of cervicothoracic junction tumors: review of 90 consecutive cases.Dimitris g.Placantonakis, m.D., ph.D.,1,2 ilya laufer, m.D.,1,2 jeremy c.Wang, m.D.,3 jasmine s.Beria, m.P.H.,1 patrick boland, m.D.,4 and mark bilsky, m.D.1,2.Doi: 10.3171/spi/2008/9/8/111.N=7 rod failure.

Manufacturer Narrative

Product complaint #
=
> (b)(4).Pc: surgical intervention.

• Brand Name: UNKNOWN RODS
• Type of Device: UNKNOWN
• 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 ; SZ
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8322651
• MDR Text Key: 135691846
• Report Number: 1526439-2019-51331
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Public: (01)UNAVAILABLE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2019
• 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?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention