MAUDE Adverse Event Report: SYNTHES GMBH 5.5MM TI MIN INVASIVE CURVED ROD 100MM RADIUS/45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 04.651.045S

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, mnh, 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) 5.5mm ti min invasive curved rod 100mm radius/45mm.This is report 5 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 =part: 04.651.045s, lot: 7549084, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 03 aug 2011, expiry date: 01 july 2021.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: part number: 04.651.045, lot number: 7513112, manufacturing site: mezzovico, release to warehouse date: 21 july 2011.A manufacturing record evaluation was performed for the non-sterile device lot number, and no non-conformances were identified.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: 5.5MM TI MIN INVASIVE CURVED ROD 100MM RADIUS/45MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11636062
• MDR Text Key: 261683113
• Report Number: 8030965-2021-02732
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07611819459465
• UDI-Public: (01)07611819459465
• Combination Product (y/n): N
• PMA/PMN Number: K093668
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Catalogue Number: 04.651.045S
• Device Lot Number: 7549084
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 04/27/2021
• Supplement Dates FDA Received: 05/11/2021
• 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; LOCK-CAP ONE-STEP F/MATRIX 5.5 TAN; MIS ROD Ø5.5 RAD 100 CURV L45 TI
• Patient Outcome(s): Required Intervention