MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number	7510800
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient was pre-operatively diagnosed with pseudoarthrosis lumbar spine, failed instrumentation and underwent the following procedure: removal of instrumentation t10-s1, reinsertion of pedicle screws t10-l5, posterior lateral fusion t10-s1, segmental instrumentation t10-s1, and fluoroscopy in which rhbmp2/acs was used.As per op-notes,¿ pedicle screws had been placed in segmental fashion from t10-s1.Prior to the fusion bilateral rods were placed in the screws and set screws were used to secure the rods to the screws and final tightening occurred after confirmatory imaging was obtained including reconnection to the iliac bolt.A stacked four rod technique was used.The fusion levels include t10-s1.To perform the fusion a high speed fluted burr was used to decorticate the levels indicated.Facetectomies had been performed as well.Once the decortication process was performed and bleeding bone was identified at the fusion levels rods were placed within the pedicle screws and set screws applied with final tightening occurring.Following this the autogenous local bone graft listed above were used to facilitate fusion.The wound was copiously irrigated with normal saline and hemostasis was obtained.Vancomycin 2gm free was placed in the wound prior to closure.A deep drain was then placed.The wound was then closed in layers.A sterile dressing was applied.The patient was then placed in the pacu extubated.The estimated blood loss and complications loss were as listed above.On (b)(6) 2016: the patient was discharged from the facility.

• Brand Name: INFUSE BONE GRAFT
• Common Device Name: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7568441
• Report Number: 1030489-2018-00800
• Device Sequence Number: 130677
• Product Code: NEK
• UDI-Device Identifier: 00681490843829
• UDI-Public: 00681490843829
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P000058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/05/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2017
• Device Catalogue Number: 7510800
• Device Lot Number: M111505AAE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 06/05/2018
• 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: Other
• Patient Age: 49 YR