MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: SYNAPSE; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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

Patient Problems Abscess (1690); Inflammation (1932)

Event Date 06/07/2021

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.This report is for an unknown construct: 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.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 review of the following journal article: ohba t.Et al.(2021), posterior occipitocervical instrumented fusion for atlantoaxial instability in a 27-month-old child with down syndrome: illustrative case, journal of neurosurgery: case lessons, vol.1 (23) (japan).This study is for 27-month-old boy with down syndrome and who was urgently transported to the authors' hospital because of difficulty in standing and sitting, weakness in the upper limbs, and respiratory distress.The procedure was performed via posterior occipitoaxial fixation with pedicle screws using intraoperative three-dimensional (3d) computed tomography (ct)-guided navigation with an o-arm scanner.A plate with rods was placed (synapse 4.0 occipito-cervico-thoracic fixation system, depuy synthes) along with artificial bone (grafton, medtronic).A postsurgical outcome and revision surgery report stated that 14 days after surgery, the patient had a fever of 38°c and a high inflammatory response in blood tests.Mri 2 weeks after surgery indicated a wound abscess and that c1¿2 spinal cord compression was relieved with decreased t2-weighted signaling, but spinal cord compression was still observed.On the basis of the above information, surgical site infection was suspected, and wound debridement and posterior arch resection were performed.The patient¿s fever disappeared from the 3rd day after the revision surgery, and his motor paralysis of the upper left limb improved further.The patient was able to maintain a sitting position 4 weeks after the reoperation and was discharged from the hospital.The patient showed modest but substantial neurological improvement 1 year after the surgery; the patient was able to maintain a standing position, shake a toy with his left hand, ingest food orally, and interact actively with his parents this report is for an unk - construct: synapse.A copy of the literature article is being submitted with this medwatch.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: SYNAPSE
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 16137234
• MDR Text Key: 307080670
• Report Number: 8030965-2023-00405
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• 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: 12/15/2022
• 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): Other
• Patient Age: 27 MO
• Patient Sex: Male