MAUDE Adverse Event Report: SYNTHES GMBH OCCIPITAL-PL 4.5/5 MED W/50 F/R Ø4 TI; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number 04.615.601

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

Patient Problem Unspecified Infection (1930)

Event Date 06/07/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in japan as follows: it was reported on june 7, 2022, that on (b)(6) 2021 the patient underwent a primary posterior cervical fusion in the occipital bone for treating vestibular neuronitis.On (b)(6) 2022 it was reported that the rod (unk) might have come off.On (b)(6) 2022 the patient underwent a revision procedure.Subsequent to the aforementioned the following reports were made: 1.The patient has become infectious including mrsa.It takes for granted that the infection was triggered by the protruded rod through the scalp.2.The lesion was cleansed on the first week of (b)(6) 2022.3.Severity of the infection was evaluated as "mild." any further symptom of the infection has not been recognized.However, the patient has been hospitalized, and the wound on the scalp needs daily treatment.No further information is available.This report is for one (1) occipital-pl 4.5/5 med w/50 f/r ø4 ti.This is report 2 of 2 for complaint pc-(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.Additional product code: kwp,mnh and mni complainant part is not expected to be returned for manufacturer review/investigation.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.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.

• Brand Name: OCCIPITAL-PL 4.5/5 MED W/50 F/R Ø4 TI
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• 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 ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 14880484
• MDR Text Key: 295123591
• Report Number: 8030965-2022-04522
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10705034740843
• UDI-Public: (01)10705034740843
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Device Operator: Health Professional
• Device Model Number: 04.615.601
• Device Catalogue Number: 04.615.601S
• Device Lot Number: 309P374
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 06/30/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female