MAUDE Adverse Event Report: SYNTHES GMBH UNK - RODS: MATRIX; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Nerve Damage (1979); Insufficient Information (4580)

Event Type  Injury  

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) to compare usage and outcomes recorded in 396 patients , 403 procedures, (136 males, 267 females) for matrix pedicle system against all other surgical cases recorded within the spine tango registry between june 01 2012 and november 12 2021.Final registry report outcome description: surgical complications - intraoperative: 17 dural lesion, 1 vascular injury.General complications - postoperative: 1 cardiovascular; 1 pulmonary; 3 kidney/urinary; 1 liver/gi; 2 other.Surgical complications - postoperative: 5 epidural hematoma, 1 other hematoma, 2 radiculopathy, 1 csf leak/pseudomeningocele, 2 motor dysfunction, 1 sensory dysfunction, 2 bowel/bladder dysfunction, 2 wound infection superficial, 3 other.Postoperative complications: 2 sensory dysfunction; 4 motor dysfunction; 3 bowel/bladder dysfunction; 1 non-union; 1 implant failure; 6 instability; 9 wound infection superficial; 4 wound infection deep; 5 epidural hematoma; 2 extravertebral hematoma; 1 recurrence of symptoms; 8 adjacent segment pathology; 1 recurrent tumor; 3 decompensation of spine; 2 cardiovascular; 7 fracture vertebral structures; 3 thromboembolism; 9 other.Reoperations: 20 reoperation at any level, reasons: -5 hardware removal; -3 non-union; -5 instability; -6 failure to reach therapeutic goal; -5 neurocompression; -1 postoperative infection deep; -2 adjacent segment pathology; -1 other 1; -8 unknown.4 reoperation at an adjacent level, reasons: -1 failure to reach therapeutic goal; -1 adjacent segment pathology; -3 unknown.8 reoperation at same level, reasons: -2 hardware removal; -1 instability; -3 failure to reach therapeutic goal; -4 neurocompression; -1 postoperative infection deep; -1 other 1; -3 unknown.-1 implant malposition, reoperation at any level.-1 implant malposition, reoperation at same level.This is for synthes spine matrix pedicle system.A copy of the clinical evaluation form is being submitted with this regulatory report.This report is for an unk - rod: matrix.This is report 5 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d1, d2, d3, d4, g4 ¿ 510k: this report is for an unknown rod: matrix/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial reporter is a synthes 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.

• Brand Name: UNK - RODS: MATRIX
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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: 18967775
• MDR Text Key: 338473774
• Report Number: 8030965-2024-04051
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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
• Date Manufacturer Received: 03/11/2024
• 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