MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN RODS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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

Patient Problems Neurological Deficit/Dysfunction (1982); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Surgical intervention in the form of revision surgery.

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown rod/ unknown lot.Part and lot number 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.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: baxter g et, al (2014), complications of growing rods used for early onset scoliosis, european spine journal vol.23 (s1), page s118, (united kingdom).The aim of this study is to identify complications experienced by patients undergoing growing rods surgery for early onset scoliosis (eos) and investigate complication rates between different growing rod implants.A total of 44 patients underwent growing rods surgery for early onset scoliosis.Of these patients, 25 patients were treated with a paediatric isola system and 7 patients were treated with a paediatric expedium.Average follow-up duration was 5 years.The article did not specify which of the devices were being used to capture the following complications: 36 patients had wound complications 3 patients had alignment complications.6 patients had general complications.7 patients had neurological complications.24 patients had implant complications.This report is for a paediatric isola system and a paediatric expedium.This report is for one unknown rod.This is report 1 of 6 for (b)(4).

• Brand Name: UNKNOWN RODS
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; 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: 9473364
• MDR Text Key: 184373554
• Report Number: 1526439-2019-52677
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2019
• 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