MAUDE Adverse Event Report: MSD DEGGENDORF MFG CLYDESDALE PTC SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 4922250

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2017

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

Pre-operative diagnosis: spinal canal stenosis(l4-l5).The type of procedure: olif (oblique lumbar interbody fusion).Levels implanted: l4-l5.It was reported that during surgery, the thread of the cage was broken due to which the cage could not be held with the inserter.The surgeon placed the cage in proper position with a remover.Due to the event there was delay in overall procedure time of less than 60 min.No patient complications were reported as a result of the event.

• Brand Name: CLYDESDALE PTC SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• Manufacturer (Section G): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7017947
• MDR Text Key: 92211334
• Report Number: 1030489-2017-02302
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00643169191327
• UDI-Public: 00643169191327
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 4922250
• Device Lot Number: 66CT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1