MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-06-29 for DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X40 N/A 01.03956.040 manufactured by Zimmer Gmbh.
[112712893]
Concomitant medical products: dynesys tl, ha pedicle screw, cannulated + set screw, 6. 0x35, item#: 01. 03956. 035, lot#: 2906964. Dynesys tl, ha pedicle screw, cannulated + set screw, 6. 0x35, item#: 01. 03956. 035, lot#: 2820446. Dynesys lis, stabilizing cord, 200, item#: 010. 3711. 200. Lot#: 2865949. Therapy date for all devices: (b)(6) 2018. The device history records were reviewed and found to be conforming. The manufacturer did not receive explanted devices for review. X-rays or other source documents were not provided for review. An e-mail requesting additional information was sent. A cause for this specific event cannot be ascertained from the information provided. As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted. Zimmer's reference number of this file is (b)(4). The following reports are associated with this event: 0009613350-2018-00486: dynesys tl, ha pedicle screw, cannulated + set screw, 6. 0x35, lot: 2906964. 0009613350-2018-00662: dynesys tl, ha pedicle screw, cannulated + set screw, 6. 0x35, lot: 2820446. 0009613350-2018-00663: dynesys tl, ha pedicle screw, cannulated + set screw, 6. 0x40 lot: 2856206. 0009613350-2018-00664: dynesys lis, stabilizing cord, 200, lot: 2865949.
Patient Sequence No: 1, Text Type: N, H10
[112712894]
It was reported that a child underwent a dynesys scoliosis tethering procedure at (b)(6) in usa. Upon returning to the (b)(6), the patient developed shortness of breath, haemothorax and lung collapse. Subsequently the implants were removed. It was further reported that the implants appeared infected. The screws were found to be cut and abutting the aorta. A screw head was occluding the right middle lobe. Note: both user reports from mhra and from fda (mw5075989) have been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009613350-2018-00663 |
| MDR Report Key | 7649723 |
| Report Source | OTHER |
| Date Received | 2018-06-29 |
| Date of Report | 2018-09-19 |
| Date of Event | 2018-02-05 |
| Date Mfgr Received | 2018-09-12 |
| Device Manufacturer Date | 2016-04-19 |
| Date Added to Maude | 2018-06-29 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER GMBH |
| Manufacturer Street | SULZER ALLEE 8 SULZER INDUSTRIE PARK |
| Manufacturer City | WINTERTHUR 8404 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 8404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNESYS TL, HA PEDICLE SCREW, CANNULATED + SET SCREW, 6.0X40 |
| Generic Name | DYNESYS TOP-LOADING SPINAL SYSTEM |
| Product Code | NQP |
| Date Received | 2018-06-29 |
| Model Number | N/A |
| Catalog Number | 01.03956.040 |
| Lot Number | 2856206 |
| ID Number | 00889024481619 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER GMBH |
| Manufacturer Address | SULZER ALLEE 8 SULZER INDUSTRIE PARK WINTERTHUR 8404 SZ 8404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-06-29 |