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

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

Patient Problems Bone Fracture(s) (1870); Nerve Damage (1979); Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown mono/polyaxial screws: uss/unknown lot.Part and lot number are unknown; udi number is unknown.Reporter is a synthes employee.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.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, rigid stabilization, and motion preserving stabilization.Failed spinal decompression, fusion, rigid stabilization, and motion preserving stabilization has been identified as per spine tango registry report experienced by the following with corresponding intervention: 19 patients had general complications: intraoperative: anaesthesiological (4), cardiovascular (4), pulmonary (1), thromboembolism (1), other (4), not documented (5).149 patients had general complications: postoperative surgical before discharge: cardiovascular (15), pulmonary (30), cerebral (8), kidney / urinary (25), liver / gi (16), thromboembolism (6), death (7), other (30), not documented (12).109 patients had surgical complications: intraoperative adverse events: nerve root damage (4), dural lesion (85), vascular injury (3), fracture vertebral structures (1), other (12), not documented (4).164 patients had surgical complications: postoperative surgical before discharge: epidural hematoma (7), other hematoma (13), radiculopathy (8), csf leak / pseudomeningocele (11), motor dysfunction (25), sensory dysfunction (16), bowel / bladder dysfunction (7), wound infection superficial (16), wound infection deep (14), implant malposition (15), implant failure (2), other (18), not documented (12).93 patients had reoperations at any level due to adjacent segment pathology (17), failure to reach therapeutic goals (9), hardware removal (17), implant failure (18), implant malposition (2), instability (11), neurocompression (7), non-union (9), other (4), postoperative infection deep (2), sagittal imbalance (2), unknown (53); 38 patients had reoperations at the same level due to adjacent segment pathology (3), failure to reach therapeutic goals (3), hardware removal (5), implant failure (7), implant malposition (1), instability (2), neurocompression (3), non-union (4), other (1), postoperative infection deep (1), unknown (23).This is for depuy synthes matrix, urs, uss, and uss fracture pedicle screw systems.This is report 8 of 9 for (b)(4).Additional reports are captured under (b)(4).

• Brand Name: UNK - CONSTRUCTS: USS
• Type of Device: ORTHOSIS, PEDICLE 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: 12220921
• MDR Text Key: 268703028
• Report Number: 8030965-2021-06067
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 09/06/2021
• Supplement Dates FDA Received: 09/07/2021
• 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