MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC OPAL SPACER 10MM X 24MM 11MM HEIGHT-REVOLVE; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Model Number	08.803.051
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Date of event: unknown.Explant date is not applicable, unknown if device was explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.
Event or Problem Description
It was reported that the patient underwent a two level minimally invasive transformation lumbar interbody fusion (mis tlif) on (b)(6) 2018 treating the lumbosacral levels 4/5 (l4/l5) and 5/1 (l5/l1) with an opal spacer.Only the spacer at the l4/5 level retro pulsed.The spacer at l5/s1 stayed in place.After six (6) weeks of taking a few falls, the patient had experienced back pain and sought out medical attention.The spacers were fixed with a pedicle screw and rod construct and those were not affected by the patient falls.Additionally, it was also reported that upon x-ray, the patients inter body spacer at the l4/l5 had retro pulsed.In order to treat the patient, the surgeon intends to perform a procedure anteriorly to remove the retro pulsed spacer and re-instrument with a locking stand-alone spacer.An anterior procedure was scheduled for (b)(6) 2018 to remove the spacer and re-instrument with an anterior spacer.This complaint involves one (1) device.This report is 1 of 1 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 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 the patient underwent a two level minimally invasive transformation lumbar interbody fusion (mis tlif) on (b)(6) 2018 treating the lumbosacral levels 4/5 (l4/l5) and 5/1 (l5/l1) with an opal spacer.There were two (2) spacers implanted on the patient, one (1) for the l4/l5 and one (1) for the l5/s1.The implants were fixed with four (4) viper cortical fix screw and two (2) viper 2 lordosed rod, ti construct.Approximately, after six (6) weeks of taking a few falls, the patient had experienced a back pain and sought out medical attention.It was also reported that upon x-ray, it was discovered that the inter body spacer at the l4/l5 had retro pulsed and the spacer implanted at the l5/s1 stayed in place.The pedicle screw and rod construct were not affected by the patient¿s falls.To treat the patient, on the surgeon performed an anterior procedure to remove the retro pulsed spacer and a synfix spacer was replaced.The opal spacer was removed successfully.There was no other serious injury or device malfunction identified during the removal surgery.As reported, there was no surgical delay and the removal surgery was completed smoothly and successfully.It was also reported that the patient was doing better.There is no other information available.Concomitant devices reported: viper 2 lordosed rod, ti (part # 1867-88-065, unknown lot #, quantity 1), viper 2 lordosed rod, ti (part # 1867-88-055, unknown lot #, quantity of 1), viper cortical fix screw (part # 1867-31-645, unknown lot #, quantity of 2), viper cortical fix screw (part # 1867-31-735, unknown lot #, quantity of 2).

• Brand Name: OPAL SPACER 10MM X 24MM 11MM HEIGHT-REVOLVE
• Common Device Name: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7483619
• Report Number: 2939274-2018-51990
• Device Sequence Number: 16551723
• Product Code: MAX
• UDI-Device Identifier: 10705034754338
• UDI-Public: (01)10705034754338
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K072791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2018

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: 08.803.051
• Device Catalogue Number: 08.803.051
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 05/29/2018
• 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: 79 YR