MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 8X45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186731845
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Pc: surgical intervention in the form of revision surgery.(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation 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 the plif surgery was performed on unknown date (about a year ago) to fix l4 with 7mm screw (p/n and lot number were unknown).After about a year from primary surgery, the patient¿s got adjacent segmental diseases.Thus, the revision surgery was performed on (b)(6) 2017 to replace 7mm screw to 8mm screw.No further information was provided by the hospital.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Complaint event description was revisited, on 3/14/2019, as a previous discussion involving medical safety officers determined that any consequence of the fusion process is due to the altered biomechanics from the fusion, not the instrumentation used to accomplish the fusion.The complaint is no longer reportable as the adjacent segment disease is not related to the instrumentation used to accomplish fusion.One (1) 5.5 ti cortical fix 8x45mm was received by the customer quality unit.Visual examination of the screw revealed significant wear with superficial indentation marks.The top part of the shank and the threads on the screw head displays apparent damage consistent with tool marks inflicted during screw removal.It was noted that the second half of the quick connect ploy screwdriver¿s tip was lodged inside the drive feature of the screw.No other anomalies were identified during device evaluation.Device history record review did not find anything that could have caused or contributed to the reported issue.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review.A root cause analysis is not required as no product problem has been identified in this complaint file, thus this reported event reports of an adverse event without an allegation of a device malfunction.As no issues could be identified in the manufacturing or release of this product that could have contributed to the problem reported.Therefore, this complaint file will be closed with no further action required.

• Brand Name: 5.5 TI CORT FIX 8X45MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8325265
• Report Number: 1526439-2019-51333
• Device Sequence Number: 1774657
• Product Code: NKB
• UDI-Device Identifier: 10705034352190
• UDI-Public: (01)10705034352190
• Combination Product (Y/N): N
• PMA/510(K) Number: K110216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2018

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 Model Number: 186731845
• Device Catalogue Number: 186731845
• Device Lot Number: 157664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 03/15/2019
• 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