MAUDE Adverse Event Report: ZIMMER SPINE UNIVERSAL CLAMP, 5.5MM TIILE; UNIVERSAL CLAMP SPINAL FIXATION SYSTEM

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 06/10/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported that a patient lost neurological signals on the left side during a deformity correction procedure.The first loss of signals occurred after a cobalt chrome rod was installed and locked into place.The surgeon loosened the set screws and removed the rod.After a short duration of time, the patient's signals returned to normal.The surgeon reduced the amount of rotational correction to the patient's spine and reinstalled and tightened a cobalt chrome rod.After the construct was completed, the patient lost neurological signals a second time.This required the prompt removal of the rod from both sides resulting in both cross connectors, all set screws and all locking screws to be removed from the patient.The pedicle screws remained in place.The surgeon then decided to change to a titanium rod instead of cobalt chrome.After this construct was completed, the patient lost neurological signals a third time.This again required the prompt removal of all set screws, all universal clamp locking screws, both rods and both cross connectors from the patient.The surgeon then made the decision to fuse the patient in-situ instead of correcting the deformity.As he sequentially tensioned and final tightened the 6 universal clamps as per the surgical technique, 3 out of the 6 locking screws on the universal clamps stripped.This resulted in the need for 3 new locking screws to be used.The patient maintained neurological signals after this final construct was installed, and the procedure was completed.In a post-case discussion with the surgeon and the anaesthetist, the repeated loss of neurological signals was due to the flexibility of the patient's musculoskeletal structure combined with the positioning of his blood vessels and spinal cord in the spinal canal.This resulted in dr gray's need to adjust his planned amount of correction and also the material of the rod during the case.It was a clinical decision that led to the need for multiple re-tightening of the universal clamps resulting in 3 new locking screws needing to be used.

Manufacturer Narrative

No product was available for return.A review of the manufacturing records did not identify any issues which would have contributed to this event.The information received states that the closure tops were installed, loosened, and reinstalled several times during the procedure.The labeling states implants are single-use only.Therefore, they are not intended to be installed multiple times.Additional information in device manufacture date and evaluation codes.This is report one of two for this event.Reference report 3003853072-2016-00157.

• Brand Name: UNIVERSAL CLAMP, 5.5MM TIILE
• Type of Device: UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; bordeaux 33080 ; FR 33080
• Manufacturer (Section G): ZIMMER SPINE; 23 parvis des chartrons; bordeaux 33080 ; FR 33080
• Manufacturer Contact: teresa george ; 23 parvis des chartrons; bordeaux 33080 ; FR 33080 ; 0003034437
• MDR Report Key: 6020482
• MDR Text Key: 57159243
• Report Number: 3003853072-2016-00123
• Device Sequence Number: 1
• Product Code: OWI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK110348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Model Number: N/A
• Device Catalogue Number: SN2027-0-20006S
• Device Lot Number: W53195
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention