MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREW/ROD CONSTRUCT ACCESSORIES: LUMBAR SPINE; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Device Problem Material Integrity Problem (2978)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/17/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - screw/rod construct accessories: lumbar spine/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 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.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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 (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the posterior spinal fusion for the osteoporotic compression fracture.The cement was injected to reinforce the screws.The surgery was completed successfully without any surgical delay.On (b)(6) 2021, kyphosis of the spine and vertebral body fracture were confirmed during consultation.He also reported that he had fallen on his behind.The patient suffers from parkinson's disease, revision or conservative treatment may be considered, and the future treatment method has not been determined yet.No further information is available.This complaint involves two (2) devices.This report is for (1) unk - screw/rod construct accessories: lumbar spine.This report is 2 of 2 for (b)(4).

• Brand Name: UNK - SCREW/ROD CONSTRUCT ACCESSORIES: LUMBAR SPINE
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• 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: 13003283
• MDR Text Key: 286247115
• Report Number: 8030965-2021-10202
• 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,Company Representative
• 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: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• 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
• Treatment: SISTEMA DE CEMENTO VERTECEM V+ . ESTERIL
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male