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

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

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown uss construct/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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

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 decompression/fusion.Failed spinal decompression/fusion has been identified as the reported complication as per spine tango registry report experienced by the following with corresponding intervention: 6 patients had general complications - postoperative surgical before discharge: pulmonary (1), kidney/urinary (1), death (1), other (3).4 patients had surgical complications - intraoperative adverse events: nerve root damage (1), dural lesion (2), other (1).2 patients had surgical complications - postoperative surgical before discharge: wound infection superficial (1), not documented (1).11 patients had reoperations at any level due to hardware removal (1), implant failure (1), implant malposition (1), and unknown (9), while 5 patients had reoperations at the same level due to hardware removal (1), and unknown (4).This is for depuy synthes spine uss fracture and schanz screws.This report is for one (1) unknown uss construct.This is report 7 of 8 for (b)(4).

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra) for 39 patients (40 procedures; 23 male and 17 female; mean age of 50.9 years) who underwent surgery using uss fracture implants recorded within the spine tango registry taken from switzerland, australia, italy, poland, and uk between january 19, 2012 and january 20, 2023.Reported complications in poland are the following: (n=3).Postoperative general complications (before discharge): (n=1) death, (n=1) other.Reoperations at any level and same level due to: (n=1) unknown.Reported complications in switzerland are the following: (n=1).Reoperations at any level due to: (n=1) unknown.Reported complications in united kingdom are the following: (n=2).Surgery follow-up complications - early (< 28 days): (n=1) wound infection superficial.Reoperations at any level due to: (n=1) unknown.Since there are adverse events/ complications reported below under unspecified country, it will be captured conservatively as follows: (n=15).Postoperative general complications (before discharge): (n=1) pulmonary, (n=1) kidney, (n=1) other.Intraoperative surgical complications: (n=1) nerve root damage, (n=2) dural lesion.Reoperations at any level due to: (n=8) unknown.Reoperations at adjacent level due to: (n=2) unknown.Reoperations at same level due to: (n=4) unknown.This is for depuy synthes spine uss fracture and schanz screws.A copy of the clinical evaluation form is being submitted with this regulatory report.

• Brand Name: UNK - CONSTRUCTS: USS FRACTURE
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11194203
• MDR Text Key: 227817554
• Report Number: 8030965-2021-00385
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

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?: Yes
• Initial Date Manufacturer Received: 12/29/2020
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 02/12/2024
• 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