MAUDE Adverse Event Report: SYNTHES GMBH TI LOCKING SCREW - STERILE; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	04.614.508
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 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: the patient has become infectious including (b)(6).It takes for granted that the infection was triggered by the protruded rod through the scalp.The lesion was cleansed on the first week of (b)(6) 2022.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) ti locking screw - sterile.This is report 1 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
Additional narrative: additional product code: kwp, mnh and nkg.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: TI LOCKING SCREW - STERILE
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 14885533
• Report Number: 8030965-2022-04521
• Device Sequence Number: 5162837
• Product Code: MNI
• UDI-Device Identifier: 10705034739229
• UDI-Public: (01)10705034739229
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2022

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
• Operator of Device: Health Professional
• Device Model Number: 04.614.508
• Device Catalogue Number: 04.614.508S
• Device Lot Number: 7L26613
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female