MAUDE Adverse Event Report: DEPUY SPINE INC UNK - RODS: MOSS-MIAMI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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

Patient Problems Hematoma (1884); Failure of Implant (1924); Nerve Damage (1979); Non-union Bone Fracture (2369); Osteolysis (2377); Impaired Healing (2378); Spinal Cord Injury (2432); Decreased Sensitivity (2683); Vertebral Fracture (4520); Joint Laxity (4526); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Type  Injury  

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) from a european spine tango registry between (b)(6) 2019 and (b)(6) 2022, with a total of 376 patients (161 males, 223 females, mean age 62.9 years) who were operated with moss miami si implants.The following complications have been identified: intraoperative complications: 31 patients had dural lesion.3 patients had fracture of the vertebral structures.Postoperative complication: 2 patients had other hematoma.1 patient had sensory dysfunction.Reoperations: 2 patients had reoperation due to adjacent segment pathology.1 patient had reoperation due to failure to reach therapeutic goals.1 patient had reoperation due to implant failure.2 patients had reoperation due to instability.1 patient had reoperation due to neurocompression.1 patient had reoperation due to non-union.1 patient had reoperation due to an unknown reason.This is for unknown depuy spine moss miami si rods.This is report 1 of 1 for complaint (b)(4).

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 rods: moss-miami/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.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) from a european spine tango registry between (b)(6) 2019 and (b)(6), 2023 with a total of (b)(4) patients ((b)(4), mean age 63.8 years) who were operated with moss miami si implants.The following complications have been identified intraoperative complications: (b)(4) patients had dural lesion.(b)(4) patients had fracture of the vertebral structures.(b)(4) patient had nerve root damage.(b)(4) patients had other intraoperative complications.Postoperative (before discharge) complications: (b)(4) patient had motor dysfunction.(b)(4) patients had other hematoma.(b)(4) patient had radiculopathy.(b)(4) patients had sensory dysfunction.Surgery follow-up complications: early (less than 28 days) surgery follow-up complications.(b)(4) cardiovascular complication sub-acute (2-6 months) surgery follow-up complications.(b)(4) sensory dysfunction.Reasons for reoperations during follow-up which ranges from early (less than 28 days), sub-acute (2-6 months), and late (more than 6 months) surgery follow-up complications.(b)(4) patients had reoperation due to neurocompression.(b)(4) patients had reoperation due to instability.(b)(4) patients had reoperation due to adjacent segment pathology.(b)(4) patients had reoperation due to non-union.(b)(4) patients had reoperation due to implant malposition.(b)(4) patients had reoperation due to failure to reach therapeutic goals.(b)(4) patient had reoperation due to spinal imbalance.(b)(4) patients had reoperation due to implant failure.(b)(4) patient had reoperation due to postoperative deep infection.(b)(4) patient had reoperation due to hardware removal.(b)(4) patient had reoperation due to cerebrospinal fluid leak.(b)(4) patients had reoperation due to other causes.(b)(4) patients had reoperation due to unknown causes.This is for unknown depuy spine moss miami si rods.This is report 1 of 5 for (b)(4).

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.

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.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 switzerland as follows: this report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) from a european spine tango registry between december 10, 2019 and june 02, 2022, with a total of 376 patients (161 males, 223 females, mean age 62.9 years) who were operated with moss miami si implants.The following complications have been identified: intraoperative complications: 31 patients had dural lesion.3 patients had fracture of the vertebral structures.Postoperative complication: 2 patients had other hematoma.1 patient had sensory dysfunction.Reoperations: 2 patients had reoperation due to adjacent segment pathology.1 patient had reoperation due to failure to reach therapeutic goals.1 patient had reoperation due to implant failure.2 patients had reoperation due to instability.1 patient had reoperation due to neurocompression.1 patient had reoperation due to non-union.1 patient had reoperation due to an unknown reason.Early (less than 28 days) surgery follow-up complications.1 cardiovascular complication sub-acute (2-6 months) surgery follow-up complications.1 sensory dysfunction reasons for reoperations during follow-up which ranges from early (less than 28 days), sub-acute (2-6 months), and late (more than 6 months) surgery follow-up complications.8 neurocompression 9 instability 7 adjacent segment pathology 3 implant malposition 3 failure to reach therapeutic goals 1 spinal imbalance 5 implant failure 1 postoperative deep infection 1 hardware removal 1 cerebrospinal fluid leak 7 other complications 9 unknown complications.This is for unknown depuy spine moss miami si rods.This is report 1 of 3 for (b)(4).

• Brand Name: UNK - RODS: MOSS-MIAMI
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 15615595
• MDR Text Key: 301849125
• Report Number: 1526439-2022-01806
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup

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?: No
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/17/2022
• Supplement Dates Manufacturer Received: 12/21/2023; 01/26/2024
• Supplement Dates FDA Received: 01/11/2024; 02/07/2024
• 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