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

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

Patient Problems Pain (1994); Non-union Bone Fracture (2369); Osteolysis (2377); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: viper/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 china as follows: this report is being filed after the review of the following journal article: wu, f.L.Et al.(2020), two-year outcomes of midline lumbar fusion versus minimally invasive transforaminal lumbar interbody fusion in the treatment of l4-l5 degenerative disease, biomedical and environmental sciences, vol.33(11), pages 839-848 (china) this study aimed to elucidate the potential advantages of midline lumbar fusion (midlf) over minimally invasive transforaminal lumbar interbody fusion (mi-tlif) by comparing the clinical outcomes, radiographical fusion rates, and complications of both approaches in larger sample size and with longer follow-ups.Sixteen consecutive patients who had undergone l4-l5 midlf for lumbar degenerative etiology since june 2017 were followed up for at least 2 years (midlf group, mean follow-up period: 26 months).As a historical control group, 34 consecutive patients who had undergone l4-l5 mitlif before june 2017 were followed up for at least 2 years after surgery (mi-tlif group, mean follow-up period: 30 months).Mi-tlif used a 6.0 mm, length 45¿50 mm, viper, medos int sarl, raynham, usa.Midlf used a 5.0 mm, length 35¿ 40 mm, expedium, depuy, raynham, usa.The mean ages for the midlf and mi-tlif groups were 68.7 ± 7.7 years and 57.7 ± 7.8 years, respectively (p < 0.001).The following complications were reported as follows: mi-tlif.1 patient had interbody migration and neurologic deficit.1 patient had adjacent segmental disease.1 patient had dura tear.4 patients had nonunion.1 patient had superficial wound infection which were transient.1 patient had urinary tract infection which were transient.1 patient had anemia which were transient.1 patient had durotomy which did not need repair.4 cases of nonunion (grade 2, bridwell classification) with low back pain during the last follow-up (average, 25 months), aggravated by the weight-bearing or a significant level of activity; however, they did not experience sciatic radiating pain, and their daily activity and work were not affected.All four cases were managed conservatively.Midlf.1 patient had screw malposition, neurologic deficit, epidural hematoma.1 patient had wound infection.1 patient had nonunion.This report is for an unknown synthes viper and expedium.A copy of the literature article is being submitted with this medwatch.This is report 2 of 5 for pc-(b)(4).

Event Description

It was noted the author did not believe the patient injuries were related to the products.

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.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.

• Brand Name: UNK - CONSTRUCTS: VIPER
• 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 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 14700877
• MDR Text Key: 294409219
• Report Number: 1526439-2022-00873
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• 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: 06/28/2022
• 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