MAUDE Adverse Event Report: EBI, LLC. SPF-XL IIB 2/DM; STIMULATOR, INVASIVE BONE GROWTH

Model Number	N/A
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Concomitant medical products: zimmer biomet polaris translation screws.Therapy date: (b)(6) 2020.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3012447612-2020-00415, 3012447612-2020-00416, 3012447612-2020-00417, 3012447612-2020-00418, 3012447612-2020-00419, 3012447612-2020-00420, 3012447612-2020-00421, 3012447612-2020-00422, 3012447612-2020-00423, 3012447612-2020-00424, 3012447612-2020-00425.
Event or Problem Description
It was reported that there was an interaction between the spf xl iib 2/dm and the cobalt chrome of the polaris translation screws.As a result, multiple screws disassembled.A revision surgery was performed to remove the screws.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow up is being submitted to relay additional information.The device was not returned for evaluation as it is still implanted in the patient.The reported event was unable to be confirmed due to limited information received from the customer.The device history record was reviewed and no discrepancies related to the reported event were found.The root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.The following sections were updated: b4: date of this report added.G1-g2: contact office updated.G4: date received by manufacturer added.G7: type of report.H2: follow up type.H3: device evaluated by manufacturer updated to no.H4: device manufacturer date added.H6: method code updated to 4114: device not returned.H6: method code updated to 3331: analysis of production records.H6: results code updated to 3221: no findings available.H6: conclusions code updated to 4315: cause not established.H10: additional narratives/data.
Event or Problem Description
It was reported that there was an interaction between the spf xl iib 2/dm and the cobalt chrome of the polaris translation screws.As a result, multiple screws disassembled.A revision surgery was performed to remove the screws.It was reported that no further information is available.

• Brand Name: SPF-XL IIB 2/DM
• Common Device Name: STIMULATOR, INVASIVE BONE GROWTH
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 10367782
• Report Number: 0002242816-2020-00083
• Device Sequence Number: 3246738
• Product Code: LOE
• UDI-Device Identifier: 00812301020089
• UDI-Public: 00812301020089
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P850035/S023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10-1335M
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 01/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention