MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN PLATES; PLATE,FIXATION,BONE

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

Patient Problems Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Reporter is (b)(6) representative.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

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra) for patients undergoing cervical laminoplasty procedures.Failed cervical or thoracic spine fusion has been identified as the reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: 3 patients had reoperation within 90 days from the index surgery.5 patients had a revision surgery within 90 days from the index surgery.6 patients had a revision surgery within 12 months from the index surgery.7 patients had a revision surgery within 24 months from the index surgery.This is for depuy spine mountaineer laminoplasty system.This report is for (1) unknown plates.This is report 3 of 8 for (b)(4).Related product complaint: (b)(4).(b)(4): unknown plates.(b)(4): unknown screws.These impacted products capture the reported reoperation within 90 days from the index surgery.(b)(4): unknown plates.(b)(4): unknown screws.These impacted products capture the reported revision surgery within 90 days from the index surgery.(b)(4): unknown plates.(b)(4): unknown screws.These impacted products capture the reported revision surgery within 12 months from the index surgery.(b)(4): unknown plates.(b)(4): unknown screws.These impacted products capture the reported revision surgery within 24 months from the index surgery.

• Brand Name: UNKNOWN PLATES
• Type of Device: PLATE,FIXATION,BONE
• 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: 10697627
• MDR Text Key: 216599386
• Report Number: 1526439-2020-01991
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• 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: 09/25/2020
• 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