MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: SPINE-US; SCREW, FIXATION, BONE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Post Operative Wound Infection (2446)

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) for patients who were treated with depuy synthes spine llif.The following complications have been identified as per the spine tango report: 2 patients died.Intraop general complications: 2 complications were not documented.Intraop adverse events: 6 complications were dural lesions.2 complications were vascular injury.2 complications were fracture vertebral structures.2 were other complications.Postop general before discharge: 3 complications were cardiovascular.1 complication was pulmonary.1 complication was thromboembolism.3 complications were not documented.Postop surgical before discharge: 1 complication was sensory dysfunction.1 complication was wound infection superficial.11 were other complications.3 complications were not documented.Reoperations: 4 patients had reoperations.This report is for an unknown acis, cervios, cervios chronos, chronos, cslp, facet wedge, ecd, matrix, opal, oracle, stenofix, synapse, synex, synfix evolution, synflate, synmesh, t-pal, uss small stature, uss, uss fracture, uss fx mis, vectra, vbs, vertecem, xrl, zero-p, zero-p va.A copy of the literature article is being submitted with this medwatch.This report is for one (1) unk - screws: spine-us.This is report 4 of 4 for complaint (b)(4).

Manufacturer Narrative

This report is for an unk - screws: spine-us/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: UNK - SCREWS: SPINE-US
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12610368
• MDR Text Key: 283138242
• Report Number: 8030965-2021-08597
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial
• Report Date: 09/13/2021

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
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 10/11/2021
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention