MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - PLATES: ANTERIOR CERVICAL LOCKING PLATE (ACLP); APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Device Problem Migration (4003)

Patient Problems Pain (1994); Post Operative Wound Infection (2446)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

Exact date of event is unknown; october 13, 2020 is the date the literature article was published.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

This report is being filed after the review of the following journal article: phillips f.M., et al (2020) prospective, multicenter clinical trial comparing m6-c compressible six degrees of freedom cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 2-year results of an fda investigational device exemption study, the spine journal volume 21, pages 239-252 (usa) this prospective study aims to report the 2-year clinical and radiographic results of an fda investigational device exemption (ide) study that compared the m6-c compressible artificial cervical disc with anterior cervical discectomy and fusion (acdf) in propensity score (ps)-matched design that included both concurrent and historical acdf controls.Between may 2014 and june 2016, a total of 258 subjects at 23 investigational sites (12 and 11 centers, respectively) in the united states were consented and enrolled in the study.(n=232) patients were treated with either to m6-c (n=160) patients and acdf (n=72) patients.Another (n=192) patients were acdf treated.A total of 160 patients (82 males and 78 females) age 43.6 - 9.1 treated with m6-cn and 189 patients (93 males and 96 females) age 44.7 - 7.9 years with acdfn were ps selected for the study.During surgery after discectomy, either the m6-c, or corticocancellous allograft and plate using one of three systems [atlantis (medtronic); vectra (depuy synthes); skyline (depuy synthes)] was implanted.The historical stryker spine acdf controls from the randomized cervicore investigational device exemption (ide) study were all treated with the reflex hybrid anterior cervical plate system.Subjects were evaluated pre-, intra-, peri-, and postoperatively at 6 weeks and 3, 6, 12, and 24 months.The follow-up rate at 24 months for composite clinical success (ccs) was (152/160) and (164/189) for the m6-c and acdf groups, respectively.The following complications were reported as follows: any serious adverse event (ae): (n=2) local infection; (n=3) neck pain; (n=3) neurologic, upper extremity; (n=3) other pain, back; (n=1) other pain, back; upper extremity nerve entrapment (n=1); trauma (n=4); and (n=2) others.12 serious ae that is either device or procedure related.1 serious ae definitely related to device or procedure (index or nonindex level).For the acdf treatment in the prospective ide one severe adverse event (sae) a subject was treated by extension of the fusion to the adjacent levels due to worsening neck and arm radiculopathy resulting in the removal of the index anterior plate system to accommodate a three-level plate system.This severe adverse event (sae) was adjudicated to be definitely related to the surgical procedure/surgery.Dysphagia rates for acdf was 6.3%.27 cases experienced pain which was manage with analgesic medications or opioid use at 24 months.2 cases of subsidence.2 cases of moderate or severe lucency.1 secondary surgical intervention(s) (ssi).This report for an unknown anterior cervical locking plate (aclp).This is report 1 of 2 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - PLATES: ANTERIOR CERVICAL LOCKING PLATE (ACLP)
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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 ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14024497
• MDR Text Key: 288697094
• Report Number: 1526439-2022-00532
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• 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