MAUDE Adverse Event Report: SYNTHES GMBH TI OCCIPITAL PLATE-MEDIAL 50MM WIDTH FOR 4.0MM RODS; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number 04.615.601S

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Drug Resistant Bacterial Infection (4553); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Concomitant medical products: date of concomitant therapy is (b)(6) 2021.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.(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 japan reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent revision surgery due to a migrated rod.The surgeon commented the following: 1.The setscrews on both ends of the plate had come off.2.The rod was about to protrude from the occipital region.3.The surgeon confirmed that final screw tightening during the primary procedure was performed.The patient underwent primary posterior cervical fusion in the occipital bone for treating vestibular neuronitis on (b)(6) 2021.The procedure was completed without surgical delay.On (b)(6) 2022, the surgeon reported that the rod might have come off.This report is for a titanium (ti) occipital plate-medial 50mm width for 4.0mm rods.This is report 3 of 3 for (b)(4).Additional reports are captured under (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: investigation summary 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 history review a manufacturing record evaluation was performed for part #: 04.615.601s, lot #: 309p374; and no non-conformances related to the malfunction were identified.

Event Description

Although there is no loosening of implants, mrsa infection is confirmed.The surgeon commented that the patient's son is on the verge of suing for lack of explanation from the manufacturer about implant problem.

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.H10 additional narrative: b5: event description updated d3: manufacturer email added updated h6 part #: 04.615.601s lot #: 309p374 manufacturing site: mezzovico release to warehouse date: 15 sept 2021 expiration date: 01 sept 2031 a manufacturing record evaluation was performed for the sterile lot number, and no non-conformances related to the malfunction were identified.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.D6a.

• Brand Name: TI OCCIPITAL PLATE-MEDIAL 50MM WIDTH FOR 4.0MM RODS
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14701444
• MDR Text Key: 294911480
• Report Number: 8030965-2022-04009
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 07611819478053
• UDI-Public: (01)07611819478053
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.615.601S
• Device Lot Number: 309P374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/15/2022
• Supplement Dates Manufacturer Received: 06/30/2022; 02/20/2023
• Supplement Dates FDA Received: 07/26/2022; 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TI LOCKING SCREW - STERILE; TI LOCKING SCREW - STERILE
• Patient Outcome(s): Required Intervention
• Patient Sex: Female