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

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

Patient Problems Pain (1994); Reaction (2414); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown screw/rod construct accessories/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between october 1987 to august 1999.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.(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: poolman, r.W., been, h.D., and ubags, l.H.(2002), clinical outcome and radiographic results after operative treatment of scheuermann¿s disease, european spine journal, vol.11 (6), pages 561-569 (netherlands).The aim of this prospective study is to evaluate radiographic findings, patient satisfaction and clinical outcome, and to report complications and instrumentation failure after operative treatment of scheuermann¿s disease using a combined anterior and posterior spondylodesis.Between october 1987 to august 1999, a total of 23 patients underwent a two-staged combined anterior and posterior spondylodesis.In 10 of these patients, a moss-miami instrumentation was used.Complete follow-up data were available for 22 patients (8 male and 14 female) with a median age of 23 years (range 16-36 years).Median follow-up was 75 months (range 25-126 months).The following complications were reported as follows: 1 patient was classified as "decompensated" (group b) postoperatively and at follow-up.4 patients had increased back pain after surgical treatment.8 patients did not note any change of back pain after surgical treatment.3 patients developed junctional kyphosis at the proximal end of the spondylodesis.A (b)(6)-year-old female patient had implant removal at 32-months.Immediate postoperative kyphosis and lordosis were 48° and 52° respectively.Follow-up kyphosis and lordosis were 64° and 70° respectively.A (b)(6)-year-old female patient had immediate postoperative kyphosis and lordosis of 46° and 48° respectively.Follow-up kyphosis and lordosis were 55° and 53° respectively.A (b)(6)-year-old female patient had implant removal at 28-months.Immediate postoperative kyphosis and lordosis were 47° and 62° respectively.Follow-up kyphosis and lordosis were 65° and 70° respectively.A (b)(6)-year-old male patient had immediate postoperative kyphosis and lordosis of 60° and 45° respectively.Follow-up kyphosis and lordosis were 65° and 55° respectively.A (b)(6)-year-old female patient had immediate postoperative kyphosis and lordosis of 48° and 50° respectively.Follow-up kyphosis and lordosis were 50° and 45 respectively.In 9 patients the implants were removed after a mean period of 2.7 years (range 1.6¿4.8 years) after the surgery.6 of these patients had implant removal due to painful prominence of hardware alone.In eight of these nine patients, serious loss of correction in the sagittal plane occurred after hardware removal, despite radiographs, bone scans and thorough intra-operative explorations demonstrating solid fusions.This report is for an unknown moss-miami.This report is for one unknown screw/rod construct accessories.This is report 7 of 7 for (b)(4).

• 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
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 9474862
• MDR Text Key: 188245139
• Report Number: 1526439-2019-52691
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 11/25/2019

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: 11/25/2019
• 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