MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.5MM TI CURVED ROD 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.636.045

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Event date can not recognized.Additional product code: mnh, mni, kwq, kwp.Occupation: synthes employee.Device is not distributed in the united states but is similar to device marketed in the usa.(b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 on an unknown date that the patient was underwent for a surgery to treat lumber spinal canal stenosis in l4-5 on (b)(6) 2020.A posterior lumber interbody fusion (plif) was performed to treat the parkinson patient.On (b)(6) it was found that the rod (04.636.045s) had come off and on (b)(6), the patient underwent a revision procedure.The surgeon was founded: the rod in l5 right had come off.The height between the set screw (09.632.099s) and the screw head (04.632.001s) fixated in l5 right was level.When the set screw was removed smoothly, no squeaking noise was generated.It did not appear that both devices had cross-threaded.There was no issue on a rod deployed in l4 right.Concomitant device reported: locking cap (part # 09.632.099s, lot # 11l4955, quantity # 1), screw head polyaxial (part # 04.632.001s, lot # h644366, quantity # 1).This is report 03 of 03 of (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.B3: event occurred on an unknown date in (b)(6) 2020, e3, g5: device is distributed in the usa and 510k information of k100952 is correct.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.

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.Investigation flow: device interaction/functional.Visual inspection: the implant was received at cq and the device appears to be in good shape, there is no evidence of damage that impacts functionality.There is no obvious visible damage that would suggest the device is inoperable.Functional test: a functional test was performed at us cq using the returned pedicle screw, rod and the locking cap.No issues were noted, the screw did not become loose and the rod stayed in place.The complaint was not able to be replicated.Therefore, the complaint is not confirmed.Dimensional inspection: based on the review of drawings, no design issues contributing to relevant complaint condition were identified.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device did not seat properly.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed part/lot combination are unknown at synthes gmbh, no dhr review possible.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 CURVED ROD 45MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9676385
• MDR Text Key: 190904565
• Report Number: 8030965-2020-00890
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07611819401976
• UDI-Public: (01)07611819401976
• 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,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.636.045
• Device Lot Number: L962358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Date Manufacturer Received: 03/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention