MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM TI OCCIPITAL SCREW 10MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	04.601.110
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent a primary pcf procedure in the occipital region.Later, on an unknown date, it was discovered that the plate and screws had come off the lesion.The patient underwent a revision procedure on (b)(6) 2022.This report is for a 4.5mm ti occipital screw 10mm.This is report 3 of 3 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: additional procode: kwp, mni, mnh.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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: 4.5MM TI OCCIPITAL SCREW 10MM
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 14915527
• Report Number: 8030965-2022-04554
• Device Sequence Number: 11270675
• Product Code: NKG
• UDI-Device Identifier: 10705034734309
• UDI-Public: (01)10705034734309
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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
• Operator of Device: Health Professional
• Device Model Number: 04.601.110
• Device Catalogue Number: 04.601.110S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OCCIPIT-SCR Ø4.5 L12 TAN; OCCIPITAL-PL 4.5/5 MED W/50 TI
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown