MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH SLENDER INSERTER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Model Number	CET30131
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint : (b)(4).Pc: no patient involvement.(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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 on an unknown date, upon arrival at the shipping pickup location, gary opened the set to discover the damage to the slender inserter and upon inspection it was noticed that there is also discoloration on the impactor.There was no patient involvement.This complaint involves two (2) devices.
Additional Manufacturer Narrative
Product complaint # (b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).H3: corrected.H4, h6: additional.Noted damage suggests that the user tried to turn the tail wheel further, even after the slender inserter stopper had hit the stop.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.With the information provided, a definitive root cause for the device failure cannot be positively determined.However, the results of the investigation suggest that the user tried to turn the tail wheel further, even after the slender inserter stopper had hit the stop.As a result, the device was torsional loaded and the stopper itself was torqued off the stopper rod.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SLENDER INSERTER
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen D-785 73
• MDR Report Key: 8804395
• Report Number: 3013730328-2019-00041
• Device Sequence Number: 13567268
• Product Code: ODP
• UDI-Device Identifier: 04260397082829
• UDI-Public: (01)04260397082829
• Combination Product (Y/N): N
• PMA/510(K) Number: K170503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CET30131
• Device Catalogue Number: CET30131
• Device Lot Number: E18DI0526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 07/30/2019; 08/21/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 08/15/2019; 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1