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

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

Patient Problems Hematoma (1884); Failure of Implant (1924); Nerve Damage (1979); Osteolysis (2377); Post Operative Wound Infection (2446); Joint Laxity (4526)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - 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 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.(b)(4).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 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: 3 patients had general complications - intraoperative: anesthesiologic (1), cardiovascular (1), pulmonary (1).11 patients had general complications - postoperative surgical before discharge: pulmonary (5), kidney/urinary (2), liver/gi (1), other (3).3 patients had surgical complications - intraoperative adverse events: nerve root damage (1), dural lesion (2).13 patients had surgical complications - postoperative surgical before discharge: epidural hematoma (1), other hematoma (3), radiculopathy (1), sensory dysfunction (1), bowel/bladder dysfunction (1), wound infection superficial (2), wound infection deep (1), other (3).16 patients had reoperations at any level due to adjacent segment pathology (3), hardware removal (3), implant failure (1), instability (2), neuro- compression (2), other (3), postoperative infection superficial (1), sagittal imbalance (1), unknown (7).4 patients had reoperations at the same level due to hardware removal (2), other (1), unknown (1).This is for depuy synthes spine synapse.This report involves one (1) unk - constructs: synapse.This report is 5 of 5 for (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.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

Updated 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.Complications reported as per spine tango registry were captured per country of event as follows: intraoperative general complications: (n=1) anaesthesiological (n=1) cardiovascular (n=1) pulmonary (1) intraoperative surgical complications: (n=2) nerve root damage.(n=2) dural lesion.(n=1) other.Postoperative general complications before discharge: (n=4) pulmonary.(n=2) liver/gi.(n=1) other.Postoperative surgical complications before discharge: (n=1) epidural hematoma.(n=3) other hematoma.(n=1) radiculopathy.(n=1) csf leak / pseudomeningocele.(n=1) sensory dysfunction.(n=2) wound infection superficial.(n=1) wound infection deep.(n=2) other.Ppostoperative complications during follow-up: (n=1) wound infection superficial.(n=1) wound infection deep.(n=1) extravertebral hematoma.(n=1) other.Reoperations due to: (n=2) hardware removal.(n=1) instability.(n=2) neurocompression.(n=1) implant failure.(n=1) adjacent segment pathology.(n=1) postoperative infection superficial.(n=2) other.(n=6) unknown.

• Brand Name: UNK - CONSTRUCTS: SYNAPSE
• 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: 11197080
• MDR Text Key: 227950570
• Report Number: 8030965-2021-00410
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• 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: 11/13/2023
• 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