MAUDE Adverse Event Report: SYNTHES GMBH 9.0MM TI MATRIX POLYAXIAL SCREW 55MM THREAD LENGTH; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	04.632.955S
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Additional 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: d2: additional procodes: kwp, mni, mnh, nkb.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial reporter is a synthes employee.H3, h6: 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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part # 04.632.955s, lot # l357529, manufacturing site: werk selzach logistik, release to warehouse date: 15.March.2017 expiration date: 01.March.2027, supplier: (b)(4).Non-sterile part # 04.632.955, non-sterile lot # h304797, manufacturing site: werk selzach logistik, release to warehouse date: 06.March.2017, supplier: synthes usa hq, inc.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 or Problem Description
Device report from japan reports an event as follows: it was reported that on (b)(6) 2018, the patient underwent an unknown procedure where l4 to s1 were fixed with matrix implants.After surgery, asd occurred and a revision surgery was scheduled.At the time of the revision procedure, the matrix screw in question was found to be loose.No further information is available.This report is for a 9.0mm ti matrix polyaxial screw 55mm thread length.This is report 1 of 1 for (b)(4).

• Brand Name: 9.0MM TI MATRIX POLYAXIAL SCREW 55MM THREAD LENGTH
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohnackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17487396
• Report Number: 8030965-2023-10030
• Device Sequence Number: 7376391
• Product Code: KWQ
• UDI-Device Identifier: 10705034745961
• UDI-Public: (01)10705034745961
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,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 Catalogue Number: 04.632.955S
• Device Lot Number: L357529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2017
• 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 Sex: Unknown