MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 3600315

Device Problem Expulsion (2933)

Patient Problem Neck Pain (2433)

Event Date 11/20/2020

Event Type  Injury  

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

Information was received from a health care professional via manufacturer representative regarding a patient with anterior cervical discectomy and fusion (acdf) surgery.It was reported that the patient had previously been treated by a different spine surgeon for an acdf and then a c3 to c7 posterior cervical fusion.The cervical plate was very mal placed and the posterior cervical construct failed.The patient was told by the pr evious surgeon that there was nothing more that they could do for them and that is when the patient went to see current doctor.The patient was re-operated on the posterior cervical fusion.Doctor extended the construct to include c2 and t1.The patient returned doctor with neck pain and films showed that the two set screws in c2 popped off or backed out, the one screw in c3 right side pulled out so doctor scheduled revision to remove the screws in c5 and c6, put a new shorter rod in c7to t1, leaving the screws which were well fixed in c2 and c4.He then closed the posteriorside and flipped the patient.On the anterior side he removed the old mal-positioned plate, and then performed an acdf from c2 to c4 using a zevo plate and screws.The set screw either backed out or popped off.Since the threads in the multiaxial screw and the threads in the set screw appeared normal the suspicion is that the set screw backed out.No further complications reported.Additional information received on 27-nov-2020: the set screw in c3 was not loose, the screw itself pulled out because the bone quality to begin with was not good.So there were only two screws that either backed out or popped off and those two set screws were in c2.There was nothing wrong with the screws in c5 or c6, the surgeon just elected to remove them, but keep the screws in at t1 and c7.

• Brand Name: INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10990752
• MDR Text Key: 220880012
• Report Number: 1030489-2020-01779
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3600315
• Device Catalogue Number: 3600315
• Device Lot Number: H5609252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2020
• Date Device Manufactured: 04/14/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 98