MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI CANCELLOUS LOCKING SCREW W/STARDRIVE RECESS 24MM; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Model Number	04.201.024
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s height reported as 185 cms.Date of event is unknown.Not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4) used to capture additional medical/surgical intervention required.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient underwent a revision on (b)(6) 2018 due to back and leg pain, spondylolisthesis, and a plate with two (2) 6 x 24 screws that had pulled-out from the s1 vertebral body.The patient was initially implanted with one (1) antegra-t plate, two (2) 6.0mm/24mm screws, one (1) 6.0mm/26mm screw, and one (1) 6.5mm/26mm screws.Two weeks post-operatively from an anterior lumbar interbody fusion spinal (alif) at l5-s1, the patient got up from the toilet and turned to flush.During the turn, he had a sudden onset of back and leg pain.The patient had returned home after the initial surgery on (b)(6) 2018, with resolution of the pre-op symptoms.The patient reported to clinic after the new pain and had x-ray and computed tomography (ct) which showed 5mm spondylolisthesis as well as the plate and two (2) 6 x 24 screws which had pulled-out of the s1 vertebral body.The s1 screws did not back out from the plate.They remained locked to the plate.A posterior surgery was planned and performed on (b)(6) 2018.Nothing was explanted.The anterior lumbar spine was never re-exposed.The revision surgery was done from the posterior.From the posterior approach, the surgeon added four (4) total screws; two (2) pedicle screws in l5, two (2) in s1, and two (2) s2ai screws in the ilium, plus rods and caps to provide stabilization and reduce the spondylolisthesis.A decompression was performed at the level and the wound closed appropriately.No surgical delay.Patient is doing well.Concomitant devices reported: 6.0mm titanium cancellous locking screw with stardrive recess 26mm (part # 04.201.026, lot # unknown, quantity # 1), 6.5mm titanium cancellous locking screw with stardrive recess 26mm (part # 04.202.026, lot # unknown, quantity # 1), titanium antegra-t plate-sterile 45mm-42mm length-sacral (part # 04.103.045s, lot # 6243776 quantity # 1).This is report 1 of 2 for 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.Additional narrative: a product development investigation was performed for the subject device: it was reported the patient underwent a revision on april 16, 2018 due to back and leg pain, spondylolisthesis, and a plate with two (2) 6 x 24 screws that had pulled-out from the s1 vertebral body.The patient was initially implanted with one (1) antegra-t plate, two (2) 6.0mm/24mm screws, one (1) 6.0mm/26mm screw, and two (2) 6.5mm/26mm screws.Two weeks post-operatively from an anterior lumbar interbody fusion spinal (alif) at l5-s1, the patient got up from the toilet and turned to flush.During the turn, he had a sudden onset of back and leg pain.The patient had returned home after the initial surgery on february 19, 2018, with resolution of the pre-op symptoms.The patient reported to clinic after the new pain and had x-ray and computed tomography (ct) which showed 5mm spondylolisthesis as well as the plate and two (2) 6 x 24 screws which had pulled-out of the s1 vertebral body.The supplied postoperative x-rays were reviewed and the complaint condition of migration could not be confirmed based on the images provided.As the device was not returned an as received, dimensional, material or drawing reviews are not applicable.No device history review was able to be completed as the device¿s lot number is unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Risk document review was completed.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: 6.0MM TI CANCELLOUS LOCKING SCREW W/STARDRIVE RECESS 24MM
• Common Device Name: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7490827
• Report Number: 2939274-2018-52048
• Device Sequence Number: 16179299
• Product Code: KWQ
• UDI-Device Identifier: 10705034733845
• UDI-Public: (01)10705034733845
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K063158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2018

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: 04.201.024
• Device Catalogue Number: 04.201.024
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 89