MAUDE Adverse Event Report: SYNTHES GMBH TI SNAP-ON TRANS-CONNECTOR 47MM-62MM FOR 5.5MM/ 6.0MM RODS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.633.347S

Device Problem Patient Device Interaction Problem (4001)

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

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j sales 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 conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a removal procedure was performed due to the patient¿s infection.The screws and the connector were removed.On (b)(6) 2018 the primary procedure was performed.The expedium verse screws, the matrix transverse connector (unk) and the cfc cage (unk) were deployed.It was unknown if the removal procedure completed successfully.The patient outcome was unknown.This complaint involves (3) devices.This report is for (1) ti snap-on trans-connector 47mm-62mm for 5.5mm/ 6.0mm rods.This report is 3 of 3 for (b)(4).

• Brand Name: TI SNAP-ON TRANS-CONNECTOR 47MM-62MM FOR 5.5MM/ 6.0MM RODS
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12235682
• MDR Text Key: 265586721
• Report Number: 8030965-2021-06128
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07611819366305
• UDI-Public: (01)07611819366305
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.633.347S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2021
• 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