MAUDE Adverse Event Report: DEPUY SPINE INC SFX,5.5,TI, MED, SIZE A4; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	189401404
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional pro-codes: osh, mni, kwp, kwq, mnh.Complainant part is not expected to be returned for manufacturer review /investigation.(b)(4).A review of the device history records has been requested and is currently pending completion.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 synthes europe reports an event in (b)(6) as follows: it was reported that the patient underwent a primary procedure with expedium system on an unknown date.On (b)(6) 2021, it was reported that two rods which were applied in the primary procedure had broken off.On (b)(6) the patient had a revision procedure (replacing rods and reinforcing the connector).The surgeon evaluated the severity of this event as ¿mild to moderate.¿ it was also reported that the surgeon will provide further information.It was also reported that the revision procedure was not desperately required.However, they chose the revision procedure to alleviate the pain which the patient had suffered since the event.This complaint involves three (3) devices.This report is for one (1) expedium sfx cross connector system connector a4 5.5 x 37-41mm.This report is 3 of 3 for (b)(4).
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.H3, h4, h6- product complaint # (b)(4).Investigation summary = 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 =a review of the receiving inspection (ri) for sfx,5.5,ti, med, size a4 was conducted identifying that lot number om7931 was released in a single batch.Batch1: lot qty of units were released on 26 jan 2013 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review = the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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: SFX,5.5,TI, MED, SIZE A4
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11624291
• Report Number: 1526439-2021-00642
• Device Sequence Number: 3920008
• Product Code: NKB
• UDI-Device Identifier: 10705034168111
• UDI-Public: (01)10705034168111
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

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
• Operator of Device: Health Professional
• Device Model Number: 189401404
• Device Catalogue Number: 189401404
• Device Lot Number: OM7931
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/17/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROD, 480 MM; ROD, 480 MM; SFX,5.5,TI, MED, SIZE A4
• Outcome Attributed to Adverse Event: Required Intervention