MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - CONSTRUCTS: EXPEDIUM VERSE; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.This report is for an unknown constructs: expedium verse/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.

Event Description

Device report from synthes reports an event in australia as follows: this report is being filed after the review of the following journal article: cundy p.J., et al (2022) persistently raised serum titanium levels after spinal instrumentation in children, spine volume 47, number 17, pp 1241¿1247 (australia).This prospective study aims to determine if levels of particular circulating metal ions are maintained to two years postsurgery including different implant systems and rods.56 children undergoing elective spinal surgery with posterior instrumentation and fusion for surgical magnitude deformity with preoperative and postoperative sampling of blood at extended time intervals were enrolled in the study.Five implant systems were utilized, namely urs (depuy synthes, johnson & johnson, new brunswick, nj), expedium (depuy synthes), verse (depuy synthes), k2m-mesa (stryker, kalamazoo, mi) and response (orthopediatrics, warsaw, in).There were 11 patients in each group apart from k2m with 12 patients giving a total of 56 patients.Of the 56 patients enrolled, 42 completed a two-year follow- up (seven patients each from response, k2m, and expedium; 10 patients from verse; and all 11 patients from urs).All had two rods inserted.Median age of patients 15.4 years (range: 11.5¿19.3; 39 female, 17 male), median 11 vertebral levels instrumented (range: 4¿16).Reported complications: expedium: preoperative titanium 0.388 , 2 y titanium 1.800, titanium levels showed a rapid increase by seven days and a peak at 30 days that was essentially maintained at the two year assay.At two years, titanium levels were 5.14 times greater compared with the presurgery control level.Preoperative chromium 0.301, 2 y chromium 0.113.Chromium and nickel levels rose immediately postoperatively and then steadily declined to baseline by six months and remained at baseline at two years.Preoperative cobalt 0.220, 2 y cobalt 0.403.Cobalt levels were shown to gradually rise to a peak at 30 days and then slowly decline but remained 1.74 times above mean baseline level at two years (p= 0.0004), with a declining trajectory.Preoperative nickel 0.542, 2 y nickel 0.143.Verse: preoperative titanium 0.626, 2 y titanium 2.520, titanium levels showed a rapid increase by seven days and a peak at 30 days that was essentially maintained at the two year assay.At two years, titanium levels were 5.14 times greater compared with the presurgery control level.Preoperative chromium 0.201, 2 y chromium 0.362.Chromium and nickel levels rose immediately postoperatively and then steadily declined to baseline by six months and remained at baseline at two years.Preoperative cobalt 0.253, 2 y cobalt 0.412.Cobalt levels were shown to gradually rise to a peak at 30 days and then slowly decline but remained 1.74 times above mean baseline level at two years (p= 0.0004), with a declining trajectory.Preoperative nickel 0.219, 2 y nickel 0.385.(1) one very high result for a single sample for nickel at 30 days was believed consistent with contamination.This report involves one unk - constructs: expedium verse.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: EXPEDIUM VERSE
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• 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: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 15824837
• MDR Text Key: 303904893
• Report Number: 1526439-2022-01974
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• 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: 10/27/2022
• 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