MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-12-16 for UNIVERSAL CLAMP ?5.5 MM TI N/A SN2027-0-20055 manufactured by Zimmer Spine.
[62541596]
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. This is report two of two for this event. Reference report 3003853072-2016-00123.
Patient Sequence No: 1, Text Type: N, H10
[62541597]
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 (b)(6) 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003853072-2016-00157 |
| MDR Report Key | 6180503 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-12-16 |
| Date of Report | 2016-12-16 |
| Date of Event | 2016-06-10 |
| Date Mfgr Received | 2016-11-16 |
| Date Added to Maude | 2016-12-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. TERESA GEORGE |
| Manufacturer Street | 23 PARVIS DES CHARTRONS |
| Manufacturer City | BORDEAUX 33080 |
| Manufacturer Country | FR |
| Manufacturer Postal | 33080 |
| Manufacturer Phone | 0003034437 |
| Manufacturer G1 | ZIMMER SPINE |
| Manufacturer Street | 23 PARVIS DES CHARTRONS CITE MONDIALE |
| Manufacturer City | BORDEAUX, CEDEX 33080 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 33080 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL CLAMP ?5.5 MM TI |
| Generic Name | UNIVERSAL CLAMP SPINAL FIXATION SYSTEM |
| Product Code | OWI |
| Date Received | 2016-12-16 |
| Model Number | N/A |
| Catalog Number | SN2027-0-20055 |
| Lot Number | W53196 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SPINE |
| Manufacturer Address | 23 PARVIS DES CHARTRONS CITE MONDIALE BORDEAUX, CEDEX 33080 FR 33080 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-12-16 |