MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: USS; ORTHOSIS, PEDICLE SPINAL FIXATION

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bone Fracture(s) (1870); Hematoma (1884); Nerve Damage (1979); Loss of Range of Motion (2032); Osteolysis (2377); Spinal Cord Injury (2432); Post Operative Wound Infection (2446); Decreased Sensitivity (2683); Thrombosis/Thrombus (4440); Unspecified Kidney or Urinary Problem (4503)

Event Type  Injury  

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.D1, d2, d3, d4, g4-510k: this report is for an unknown constructs: uss/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h4, h6: 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 switzerland as follows: this report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing spinal surgery failed spinal surgery has been identified as the reported complication as per spine tango registry report experienced by the following with corresponding intervention: 4 patients died.General complications - intraop general complications -3 patients had anaesthesiologica complications -4 patients had cardiovascular complications -1 patient had pulmonary complications -1 patient had thromboembolism -3 patients had other complications -3 patients had unknown complications general complications - postop surgical before discharge -7 patients had cardiovascular complications -17 patient had pulmonary complications -6 patients had cerebral complications -12 patients had kidney/urinary complications -7 patients had liver/gi complications -3 patients had thromboembolism -15 patients had other complications -4 patients had complications that were not documented -3 patients had unknown complications surgical operations - intraop adverse events -1 patient had nerve root damage -30 patients had dural lesions -2 patients had vascular injuries -1 patient had a fracture vertebral structures -4 patients had other complications -3 patients had unknown complications surgical operations - postop surgical before discharge -1 patient had epidural hematoma -5 patients had other hematomas -1 patient had radiculopathy -5 patients had csf leak/psedomeningocele -13 patients had motor dysfunctions -12 patients had superficial wound infections -7 aptients had deep wound infections -3 patients had iimplant malpositions -8 patients had other complications -3 patients had complications that were not documented -3 patients had unknown complications reoperation -25 patients had reoperations because of adjacent segment pathology -17 patients had reoperations because of failing to reach their therapeutic goals -55 patients had reoperations because of hardware removal -37 patients had reoperations because of implant failure -33 patients had reoperations because of instability -13 patients had reoperations because of neurocompression -18 patients had reoperations because of nonunion -15 patients had reoperations because of other complications -9 patients had reoperations because of postop deep infections -3 patients had reoperations because of postop superficial infection -4 patients had reoperations because of sagittal imbalance -57 patients had reoperations because of unknown complications this is for depuy synthes spine uss implants.This is report 2 of 6 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.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

Additional adverse events reported: early (less than 28 days) surgery follow-up complications.6 adjacent segment pathology, reoperation.1 bowel/ bladder dysfunction.2 decompensation of spine.1 epidural hematoma.1 extravertebral hematoma.11 fracture vertebral structures.1 implant failure, reopration.1 implant malposition, reoperation.7 motor dysfunction.1 recurrence of symptoms.5 sensory dysfunction.1 thromboembolism.1 deep wound infection.2 superficial wound infection.3 reoperation due to neurocompression.1 reoperation due to failure to reach therapeutic goals.Hardware removal (total of 12).Sub-acute (2-6 months) surgery follow-up complications.1 csf leak/ pseudomeningocele.1 extravertebral hematoma.1 fracture vertebral structures.1 graft complication.4 implant failure, reoperation.1 motor dysfunction.1 recurrence of symptoms.1 sensory dysfunction.1 deep wound infection, reoperation.1 superficial wound infection, reoperation.1 reoperation due to failure to reach therapeutic goals.Hardware removal (total of 12).Late (more than 6 months) surgery follow-up complications.1 csf leak/ pseudomeningocele.6 implant failure, reoperation.1 instability, reoperation.1 motor dysfunction.1 recurrence of symptoms.2 sensory dysfunction.1 reoperation due to instability.Hardware removal (total of 12).Reasons for reoperation.(adjacent segment).2 hardware removal.1 instability.2 implant failure.2 adjacent segment pathology.2 neurocompression.3 other reasons.5 unknown reasons.(same level).6 hardware removal.3 implant failure.1 adjacent segmentpathology.1 neurocompression.2 failure to reachtherapeutic goals.1 postoperativeinfection deep.2 other reasons.31 unknown reasons.

• Brand Name: UNK - CONSTRUCTS: USS
• Type of Device: ORTHOSIS, PEDICLE SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18443568
• MDR Text Key: 331908424
• Report Number: 8030965-2024-00221
• Device Sequence Number: 1
• Product Code: MNI
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• 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: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention