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

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

Patient Problems Thromboembolism (2654); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unk - constructs: uss ii/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 (b)(6) as follows: 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 surgery.Failed spinal surgery has been identified as the reported complication as per spine tango registry report experienced by the following with corresponding intervention: 4 patients died.General complications ¿ intra-op general complications 3 patients had anesthesiologic complications, 4 patients had cardiovascular complications, 1 patient had pulmonary complications, 1 patient had thromboembolism, 3 patients had other complications, 3 patients had unknown complications.General complications - postop surgical before discharge 7 patients had cardiovascular complications, 17 patient had pulmonary complications, 6 patients had cerebral complications, 12 patients had kidney/urinary complications, 7 patients had liver/gi complications, 3 patients had thromboembolism, 15 patients had other complications, 4 patients had complications that were not documented, 3 patients had unknown complications.Surgical operations ¿ intra-op adverse events 1 patient had nerve root damage, 30 patients had dural lesions, 2 patients had vascular injuries, 1 patient had a fracture vertebral structure, 4 patients had other complications, 3 patients had unknown complications.Surgical operations - postop surgical before discharge 1 patient had epidural hematoma, 5 patients had other hematomas, 1 patient had radiculopathy, 5 patients had csf leak/psedomeningocele, 13 patients had motor dysfunctions, 12 patients had superficial wound infections, 7 patients had deep wound infections, 3 patients had implant malposition, 8 patients had other complications, 3 patients had complications that were not documented, 3 patients had unknown complications.Reoperation 25 patients had reoperations because of adjacent segment pathology, 17 patients had reoperations because of failing to reach their therapeutic goals, 55 patients had reoperations because of hardware removal, 37 patients had reoperations because of implant failure, 33 patients had reoperations because of instability, 13 patients had reoperations because of neuro compression, 18 patients had reoperations because of nonunion, 15 patients had reoperations because of other complications, 9 patients had reoperations because of postop deep infections, 3 patients had reoperations because of postop superficial infection, 4 patients had reoperations because of sagittal imbalance, 57 patients had reoperations because of unknown complications.This is for depuy synthes spine uss and uss ii implants.The complaint involves 12 (twelve) devices.This report involves one (1) unk - constructs: uss ii.This is report 4 of 10 for (b)(4).Related product complaint: (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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

Additional information indicating surgical complications at follow-up was received and captured on related complaint (b)(4).

• Brand Name: UNK - CONSTRUCTS: USS II
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11223468
• MDR Text Key: 232866343
• Report Number: 8030965-2021-00591
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• 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: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention