MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME CFXFEN XTAB 6X50MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186760450S
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Codes	Fatigue (1849); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the patient underwent a revision of the transforaminal lumbar interbody fusion (tlif) of the l4-s1 to remove lose l4 screws and the cage posteriorly.The cage was occupying the foramen.The patient was experiencing moderate back pain and leg muscle weakness following the primary procedure.The l4 screws were replaced and the cage was removed/replaced.Concomitant device: viper prime cfxfn xtb 7x55mm s (part# 186770455s, lot# unknown, qty 2).This report is for (1) viper prime cfx fen x-tab polyaxial screw 5.5 6 x 50mm.This is report 2 of 2 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.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.G1.
Event or Problem Description
It was further reported that during hardware removal procedure inserter was unable to connect to back of cage (evidence of stripping).This intra-op event has been reported under related complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d4: lot.H3, h6: the dhr of product code: 186760450s.Lot : tbwbj.Was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: (b)(6) 2018.Qty: 200.Visual inspection: viper prime cfxfen xtab 6x35mm (part# 186760450, lot# tbwbj, qty# 1) was returned and received at us customer quality (cq).Upon visual inspection at cq, it was observed that there are no issues identified on the returned device but dry bone cement could be seen inside the screw head.Thus, the complaint cannot be confirmed.Functional test: functional test was not performed on the returned device due to the device received by itself.Can the complaint be replicated with the returned device? unable to perform.Dimensional inspection: no dimensional inspection was performed as there was no damage that warranted dimensional inspection.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed.- viper prime screw assy.Complaint confirmed? no.Investigation conclusion: the complaint cannot be confirmed for viper prime cfxfen xtab 6x35mm as no defects were identified with the returned device.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 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.D1, d3, d4: catalog and udi.

• Brand Name: VIPER PRIME CFXFEN XTAB 6X50MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12093933
• Report Number: 1526439-2021-01346
• Device Sequence Number: 11763383
• Product Code: NKB
• UDI-Device Identifier: 10705034530109
• UDI-Public: 10705034530109
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170543
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2021

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: 186760450S
• Device Catalogue Number: 186760450
• Device Lot Number: TBWBJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 07/05/2021; 08/13/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 08/02/2021; 08/31/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONCORDE PROTI, 5DG,9X12X27 MM; VIPER PRIME CFXFN XTB 6X50MM S; VIPER PRIME CFXFN XTB 7X55MM S
• Outcome Attributed to Adverse Event: Required Intervention