MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP 6.35 TI POLY 9 X 85MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179912985
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Tissue Injury (4559)
Date of Event	12/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: kwp; kwq; mnh; mni; osh.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 that on (b)(6) 2020, during an unknown procedure after placing the right iliac screw on this patient, the surgeon noticed that he was not able to fit in a rod.The screw was removed and the inner head of the screw was damaged.The inner mechanism of the head was turned off axis with the outer head.The screw was replaced with a larger diameter screw.Patient status is unknown.The procedure was successfully completed.This report is for one (1) exp 6.35 ti poly 9 x 85mm.This is report 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: the device history record (dhr) of product code 179912985, lot 188582, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on march 21, 2018.Visual : the exp 6.35 ti poly 9 x 85mm was received at us customer quality (cq).Upon visual inspection, it was noticed that the screw cap was off axis/twisted inside the screw assemble.The twisted condition of the screw cap could have resulted in the reported complaint condition.No other defects were identified on the device.Dimensional analysis: no dimensional analysis was performed due to confirmed identification of the defect and components being unable to be accessed without dismantling the assembly.Summary: the complaint condition is confirmed for the exp 6.35 ti poly 9 x 85mm.No definitive root cause could be determined based on the provided information.No new, unique, or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: EXP 6.35 TI POLY 9 X 85MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11190049
• Report Number: 1526439-2021-00165
• Device Sequence Number: 19024449
• Product Code: NKB
• UDI-Device Identifier: 10705034087108
• UDI-Public: (01)10705034087108
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

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: 179912985
• Device Catalogue Number: 179912985
• Device Lot Number: 188582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 02/26/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN RODS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 111