MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN MONO/POLYAXIAL SCREWS; SCREW,FIXATION,BONE

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Code Available (3191)

Event Date 02/19/2012

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.(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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: yu ch, chen pq, ma sc, pan ch (2012).Segmental correction of adolescent idiopathic scoliosis by all-screw fixation method in adolescents and young adults.Minimum 5 years follow-up with sf-36 questionnaire, scoliosis journal, volume 7, pages 1-8, (taiwan).The purposes of the current study were to evaluate the intermediate-term (more than 5 years) effectiveness and safety profile of the all-screw fixation method in the treatment of idiopathic scoliosis.The functional outcome and quality of life were assessed by means of an established questionnaire.Between september 2001 to december 2003, 49 patients with adolescent idiopathic scoliosis who underwent treatment using the all-screw method were included in the study.There were 38 females and 11 males with a mean age of 18.5 years (range, 11.7-31.4 years) at the time of surgery.There were 2 patients who were implanted with an unknown depuy spine moss-miami screw system while the rest of the patients were implanted with competitors¿ screws.A total of 831 pedicle screws were inserted.The mean number of pedicle screws inserted per patient was 17 (range, 10-24).The minimum follow-up was 5 years (mean, 6.1 years; range, 5.1-7.3 years).The authors did not specify which patients were implanted with the moss-miami screws.Thus, complications will be reported as follows: 56 screws were found to be malpositioned and most of them were situated in the thoracic spine.16 screws were found inferiorly, 25 found laterally, and 15 superiorly to the pedicle.No patients sustained a nerve root injury during surgery.2.4 degrees of average correction loss for all patients after a minimum of 5 years follow-up.Unknown patients showed limitations on their physical health, as assessed by the sf-36 questionnaire.Depuy spine product: this report is for the unknown depuy moss-miami screw system (depuy spine, (b)(4)).This is report 1 of 2 for (b)(4).

• Brand Name: UNKNOWN MONO/POLYAXIAL SCREWS
• Type of Device: SCREW,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 ; SZ
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 9553411
• MDR Text Key: 189364128
• Report Number: 1526439-2020-00173
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• 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: 12/10/2019
• 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