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 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, g4 ¿ 510k: this report is for an unknown construct: uss fracture/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.

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 (b)(6) 2012 and (b)(6) 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 report is for an unk - construct: uss fracture.A copy of the clinical evaluation form is being submitted with this regulatory report.This is report 1 of 2 for (b)(4).

• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18695061
• MDR Text Key: 335249592
• Report Number: 8030965-2024-02319
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• 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: 01/31/2024
• 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