MAUDE Adverse Event Report: DEPUY SPINE INC AXIAL CON 3.5-4 TO 5.5-6.35; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	1020-19-004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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 or Problem Description
It was reported that on (b)(6) 2021, a revision case was reported for set screws due to product failure.Patient complains of pain.Patient and procedure outcome were unknown.This complaint involves six (6) number of devices.This report is for (1) axial con 3.5-4 to 5.5-6.35.This report is 2 of 7 (b)(4).
Additional Manufacturer Narrative
Product complaint#: (b)(4).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, h6: investigation summary investigation flow: functional: visual inspection: axial con 3.5-4 to 5.5-6.35 (part#: 102019004, lot#: 257119, qty#: 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that the device was deformed.Which might be due to the revision operation.Which would not contribute to the complaint condition.Functional test: a functional test could not be performed as the device was returned by itself, but the alleged migration condition can be confirmed from the x ray provided.Since the x ray shows the rod slipping out from the connector.The complaint can not be replicated with the returned device(s).Dimensional inspection: a dimensional inspection was not performed due to relevance to complaint condition.Document/specification review: no design issues or discrepancies were found during this investigation.The complaint was confirmed.Investigation conclusion: the complaint can be confirmed for axial con 3.5-4 to 5.5-6.(part#: 102019004, lot#: 257119, qty#: 1).A definitive root cause could not be identified for the reported problem.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: the dhr of product code: 102019004.Lot : 257119 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 10.26.2019.Qty: 40.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: AXIAL CON 3.5-4 TO 5.5-6.35
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11859279
• Report Number: 1526439-2021-01022
• Device Sequence Number: 19878959
• Product Code: NKG
• UDI-Device Identifier: 10705034518886
• UDI-Public: 10705034518886
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K181949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1020-19-004
• Device Catalogue Number: 102019004
• Device Lot Number: 257119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 06/10/2021; 06/14/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 06/11/2021; 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AXIAL CON 3.5-4 TO 5.5-6.35.; SET SCREW.; SET SCREW.; SET SCREW.; SET SCREW.; UNKNOWN RODS.; UNKNOWN SCREWS.
• Outcome Attributed to Adverse Event: Required Intervention