MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: ZERO-P; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

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

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, g5-510k: this report is for an unk - constructs: zero-p /unknown lot.Part and lot number are unknown.Without the specific part number; the udi 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 belgium as follows: this report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra) to compare usage and outcomes recorded in 310 patients (148 males, 145 females) for zero-p implants against all other surgical cases recorded within the spine tango registry between 2012 to 2023.The following complications were recorded per country (belgium): surgical complications - postoperative before discharge: 1 implant malposition.Reoperations: reoperations at any level: 2 due to failure to reach therapeutic goals, 1 due to neurocompression, 3 due to unknown.Reoperations at adjacent level: 2 due to failure to reach therapeutic goals, 1 due to neurocompression.Reoperations at same level: 2 due to failure to reach therapeutic goals, 1 due to neurocompression.This is for depuy synthes zero-p and chronos.This is report 3 of 4 for complaint (b)(4).A copy of the clinical evaluation form is being submitted with this regulatory report.

• Brand Name: UNK - CONSTRUCTS: ZERO-P
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS 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: 18515111
• MDR Text Key: 332891190
• Report Number: 8030965-2024-00847
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 01/15/2024
• 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: 12/21/2023
• 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