MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIX LOCKING CAP; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Catalog Number 04.632.000S

Device Problem Mechanical Problem (1384)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Additional device product codes: kwq, mni, nkb, and kwp.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.(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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent revision of spondylodesis due subsequent degeneration of the lumbar-thoracic connecting segments.The locking caps had to be removed in order to close them again after the connection segments were instrumented.The patient was first treated in the year 2009.There was no surgical delay.The procedure was successfully completed.There was no patient consequence reported.This report involves one (1) ti matrix locking cap.This is report 4 of 6 for (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.H3, h4, h6- 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 lot =sterile-part, part: 04.632.000s, lot: 7656909, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 10.Nov.2011, expiry date: 01.Nov.2021.Since there is no allegation against packing or sterility, a manufacturing record evaluation was not performed.Part number:04.632.000, synthes lot number: 6792589, supplier lot number: n/a, release to warehouse date: 11oct2011, expiration date: n/a, manufactured by synthes brandywine.No ncrs were generated during production.Device history review =review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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 appropriat.

• Brand Name: TI MATRIX LOCKING CAP
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11636022
• MDR Text Key: 261683705
• Report Number: 8030965-2021-02731
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 07611819364912
• UDI-Public: (01)07611819364912
• Combination Product (y/n): N
• PMA/PMN Number: K100952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2021
• Device Catalogue Number: 04.632.000S
• Device Lot Number: 7656909
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2021
• Patient Sequence Number: 1
• Treatment: LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN; LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN; LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN; MIS ROD Ø5.5 RAD 100 CURV L45 TI; MIS ROD Ø5.5 RAD 100 CURV L45 TI
• Patient Outcome(s): Required Intervention