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

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Hematoma (1884); Failure of Implant (1924); Nerve Damage (1979); Post Operative Wound Infection (2446); Decreased Sensitivity (2683); Vertebral Fracture (4520); Unspecified Tissue Injury (4559)

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: 510k: this report is for an unknown constructs: synapse/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 a j&j 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

Device report from synthes reports an event in switzerland as follows: this report filled after the review of a clinical evaluation report(cer)from a related research activity database(drra): spine tango implant report ¿ synapse (all) between january 16, 2012 and january 18, 2022, with a total of 152 patients (158 procedures; 101 male and 57 female; mean age of 63.0 years) who were operated with depuy synthes spine synapse system.The following complications have been identified: general complications - intraoperative: 1 patient had anaesthesiological, 1 patient had cardiovascular, 1 patient had pulmonary, general complications-postoperative, 1 patient had cardiovascular, 8 patients had pulmonary, 3 patients had kidney/urinary, 3 patients had liver/gi, 3 patients had other complications surgical complications - intraoperative, 2 patients had nerve root damage, 3 patients had dural lesion, 1 patient gad fracture vertebral structures, surgical complications - postoperative, 1 patient had epidural hematoma, 3 patients had other hematoma, 1 patient had radiculopathy, 1 patient had csf leak/ pseudomeningocele, 1 patient had motor dysfunction, 1 patient had sensory dysfunction, 1 patient had bowel/bladder dysfunction, 3 patients had wound infection superficial, 2 patients had wound infection deep, 1 patient had implant failure, 3 patients had other complications, postoperative complications: 1 patient had instability, 1 patient had wound infection superficial, 1 patient had wound infection deep, 1 patient had extravertebral hematoma, 2 patients had recurrence symptoms, 2 patients had other complications, reoperations: 17 patients had reoperation at any level, 6 patients had reoperation at an adjacent level, 6 patients had reoperations at same level, 2 patients had reoperation due to hardware removal, 1 patient had reoperation due to instability, 2 patients had reoperation due to neurocompression, 1 patient had reoperation due to postoperative infection superficial, 1 patient had reoperation due to implant failure, 2 patients had reoperation due to adjacent segment pathology, 3 patients had reoperation due to other complications, 11 patients had reoperation due to unknown complications, this report involves one unk - constructs: synapse.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: SYNAPSE
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW 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: 15620187
• MDR Text Key: 301898717
• Report Number: 8030965-2022-08290
• Device Sequence Number: 1
• Product Code: NKB
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• 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: 09/26/2022
• 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