MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-27 for S4 ELEMENT MIS ROD CALIPER FW774R manufactured by Aesculap Inc.
[132386249]
(b)(4). Manufacturing site evaluation: evaluation on-going. Investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[132386250]
It was reported that there was an issue with the s4 element mis rod caliper during surgery. On (b)(6) 2018, the patient underwent a lumbar fusion. When the surgeon placed the rod caliper in the down tube to measure rod length, it would not come out. The surgeon eventually used a mallet to remove it, and then the saddle from the screw came out with it. The tip of the rod caliper had lodged into the female part of the saddle, and that part of the screw came out with the caliper. A five minute delay in surgery was noted. There was no injury to the patient and no additional medical intervention required. Additional details regarding clarification of the event were provided on (b)(6) 2018. Details: inside the pedicle screw there is a "saddle" where the rod sits. The rod caliper got lodged into the saddle and when the surgeon pulled the caliper out, the saddle came out with it. He removed the screw and replaced it with a new screw. The caliper was not damaged and no fragments were left in the patient. There were no adverse outcomes, it took approximately 5 minutes to remove and replace the screw. This report addresses the malfunction of the rod caliper. Associated medwatches: 9610612-2018-00620.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00604 |
| MDR Report Key | 8200010 |
| Date Received | 2018-12-27 |
| Date of Report | 2019-02-22 |
| Date of Event | 2018-11-28 |
| Date Facility Aware | 2019-02-18 |
| Date Mfgr Received | 2019-02-18 |
| Date Added to Maude | 2018-12-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. NICOLE BROYLES |
| Manufacturer Street | 1 A RAUMANTIE |
| Manufacturer City | HELSINKI 00350 |
| Manufacturer Country | FI |
| Manufacturer Postal | 00350 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | S4 ELEMENT MIS ROD CALIPER |
| Generic Name | INSTRUMENTS POSTERIOR STABILIZATION |
| Product Code | FTY |
| Date Received | 2018-12-27 |
| Model Number | FW774R |
| Catalog Number | FW774R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP INC |
| Manufacturer Address | 615 LAMBERT POINTE DRIVE HAZELWOOD 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-27 |