MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - PLATES: SKYLINE; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Nerve Damage (1979); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: the current report is a retrospective analysis of 133 patients (57 females and 76 males) who underwent instrumentation with cervios between (b)(6) 2006, and (b)(6) 2020.In 1 case it was combined with skyline.15 cases combined with anterior non-depuy devices were excluded, leaving 118 cases for analysis.Mean age of the patients was 51 years.Registered intra-operative complications: 1 dural tear, 3 root injury, 2 other.Reinterventions during index stay: 1 adjustment implant.Registered post-op complications within 1 year: 15 dysphagia, 10 recurrent nerve injury.Readmissions: 1 redecompression.1 subsequent reoperation at a new index level.Global assessment of neck pain (ga) failure % : fu 1 yrs.49%, fu 2 yrs.48% fu 5 yrs.47%.Global assessment of arm pain (ga) failure % : fu 1 yrs.40%, fu 2 yrs.40% fu 5 yrs.47%.This is for depuy spine skyline.This report is for one (1) device report from synthes reports an event in (b)(6) as follows: the current report is a retrospective analysis of 133 patients (57 females and 76 males) who underwent instrumentation with cervios between (b)(6) 2006, and (b)(6) 2020.In 1 case it was combined with skyline.15 cases combined with anterior non-depuy devices were excluded, leaving 118 cases for analysis.Mean age of the patients was 51 years.Registered intra-operative complications: 1 dural tear.3 root injury.2 other.Reinterventions during index stay: 1 adjustment implant.Registered post-op complications within 1 year: 15 dysphagia.10 recurrent nerve injury.Readmissions: 1 redecompression.1 subsequent reoperation at a new index level.Global assessment of neck pain (ga) failure % : fu 1 yrs.49%, fu 2 yrs.48% fu 5 yrs.47% global assessment of arm pain (ga) failure % : fu 1 yrs.40%, fu 2 yrs.40% fu 5 yrs.47% this is for depuy spine skyline.This report is for one (1)unk - plates: skyline.This is report 2 of 6 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).510k: this report is for an unk - plates: skyline/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5: updated event description d3: updated manufacturer email g1: updated manufacturer contact information h6: updated health effect - clinical codes 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

Updated: this report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) "depuy spinal implants subreport 15 ¿ cervios" for a total of (b)(6)patients ((b)(6)were females) who underwent instrumentation with cervios between (b)(6) 2006 and (b)(6), 2022.In 2 cases it was combined with skyline.15 cases combined with anterior non-depuy devices were excluded, leaving 118 cases for analysis.Mean age of the patients was 51 years.Complications reported in swedish spine registry (swespine) were: registered intra-operative complications (n=5): - 1 dural tear - 1 hematoma - 1 root injury - 2 other registered post-op complications within 1 year (n=27): - 16 dysphagia - 11 recurrent nerve injury reoperations (n=2): - 1 adjustment implant - 1 redecompression this is for depuy spine skyline.This report is for one (1)unk - plates: skyline this is report 2 of 6 for complaint pc-(b)(4).

• Brand Name: UNK - PLATES: SKYLINE
• 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 ; 8472871282
• MDR Report Key: 12705154
• MDR Text Key: 284291870
• Report Number: 1526439-2021-02264
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 03/24/2023
• 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