MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN CAGE/SPACER; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

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

Patient Problems Nerve Damage (1979); Perforation of Vessels (2135); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown cage/spacer/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.Reporter is a j&j employee.(b)(4).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 a clinical evaluation report (cer) from a database related research activity (drra) for a total of 431 patients (432 procedures) who were operated with depuy synthes implants against all other alif procedures recorded within the spine tango registry from (b)(6) 2005 to (b)(6) 2019.There were 276 females and 156 males with a mean age of 59 years.Intraoperative surgical complications: (n=1) nerve root damage, (n=3) dural lesion, (n=4) vascular injury, (n=8) other, (n=8) unknown.Intraoperative general complications: (n=1) not documented, (n=8) unknown.Postoperative general complications: (n=1) cardiovascular, (n=1) pulmonary, (n=1) liver/gi, (n=7) not documented, (n=1) other, (n=8) unknown.Postoperative surgical complications: (n=6) other hematoma, (n=1) radiculopathy, (n=2) motor dysfunction, (n=1) sensory dysfunction, (n=2) implant failure, (n=7) not documented, (n=8) unknown, (n=1) implant malposition.Postoperative complications: (n=5) sensory dysfunction, (n=5) motor dysfunction, (n=2) bowel/bladder dysfunction, (n=1) non-union, (n=5) implant failure, (n=3) instability, (n=7) wound infection superficial, (n=1) wound infection deep, (n-=1) epidural hematoma, (n=1) extravertebral hematoma, (n=6) recurrence of symptoms, (n=3) adjacent segment pathology, (n=1) decompensation of spine, (n=3) fracture vertebral structures, (n=1) thromboembolism, (n=11) other, (n=1) implant malposition.Reoperations at any level: (n=5) hardware removal, (n=2) non-union, (n=5) instability, (n=2) failure to reach therapeutic goals, (n=1) postop deep infection, (n=5) implant failure, (n=2) adjacent segment pathology, (n=3) other, (n=16) unknown.Reoperations at same level: (n=3) hardware removal, (n=3) instability, (n=2) failure to reach therapeutic goals, (n=1) postop deep infection, (n=2) implant failure, (n=2) adjacent segment pathology, (n=2) other, (n=4) unknown.This complaint is for the unknown depuy spine expedium, unknown depuy spine viper, unknown depuy spine cougar, unknown depuy spine aegis , unknown depuy spine devex, unknown depuy spine harms cage, unknown depuy spine expedium verse, unknown depuy spine cobra and unknown depuy spine atp plate.This report is for unknown cage/spacer.This is report 6 of 6 for complaint (b)(4).

Event Description

Additional complications were reported: 9 australia surgical forms, no complications for 8 forms and one case of liver / gi postoperative general complication before discharge.

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, h6: health effect - clinical code.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: UNKNOWN CAGE/SPACER
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• 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 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13663562
• MDR Text Key: 288998579
• Report Number: 1526439-2022-00321
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• 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?: No
• Date Manufacturer Received: 06/10/2022
• 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