MAUDE Adverse Event Report: K2M, INC. STRAIGHT ROD, DUAL HEX; SIZE 3.5X400 MM, COCR; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	1111-B35400
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Return status unknown.
Event or Problem Description
A physician reported that an oct system straight rod, dual hex, cocr fractured 3 months post-operatively.Revision surgery was performed.
Event or Problem Description
A physician reported that an oct system straight rod, dual hex, cocr fractured 3 months post-operatively.Revision surgery was performed.
Additional Manufacturer Narrative
Visual, dimensional and functional analysis could not be performed as the device was not returned.However, through x-ray analysis; the reported rod was seen to be fractured between t10 and l2 level.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.According to the ifu; physical activity and load bearing have been implicated in premature loosening, bending or fracture of internal fixation devices.Metallic implants are not as strong as a normal, healthy bone and will fracture under normal load bearing in the absence of complete bone healing.It could not be determined if fusion was achieved.Incidence of pseudoarthrosis could allow for continued dynamic motion within the construct, which may contribute to a failure of this nature.It was not confirmed if the patient was involved in strenuous activities, which could also introduce unanticipated loading within the construct, leading to rod fracture.

• Brand Name: STRAIGHT ROD, DUAL HEX; SIZE 3.5X400 MM, COCR
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9527259
• Report Number: 3004774118-2019-00169
• Device Sequence Number: 11457457
• Product Code: NKG
• UDI-Device Identifier: 10888857018082
• UDI-Public: 10888857018082
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K153370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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: 1111-B35400
• Device Catalogue Number: 1111-B35400
• Device Lot Number: BWKP
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 11/23/2020
• 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