MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2012-10-30 for BREMER LARGE PEDIATRIC RING PT022 manufactured by Depuy Raynham.
[10564897]
The pediatric ring was not returned for evaluation. However, as reported by the affiliate, the device did not malfunction. Reports it was a matter of selection, voice of customer, and complaint/concern of product design for child with larger head width/diameter. Reports the size of ring does not fit with the shape of the skull of (b)(6). No other complaints of this nature have been reported within the past twelve months. Depuy synthes spine's product portfolio includes custom ring set,(child or adult), product code ht014, which may have been be an alternative product for this patient. At this time, the complaint is considered to be closed. Device not available.
Patient Sequence No: 1, Text Type: N, H10
[18810476]
International affiliate reports (b)(6) old patient has a larger head width than usual. The large pediatric halo ring was not large enough for the patient. The surgeon used a 3d halo crown systems instead. Surgery time was extended to 120 minutes to collect and prepare the halo crown. Affiliate reports the halo ring does not fit with the shape of the skull of (b)(6) children. The affiliate has confirmed that the halo crown did not malfunction. Reports it was a matter of selection, voice of customer, and complaint for product design.
Patient Sequence No: 1, Text Type: D, B5
[19061806]
Depuy synthes spine has requested return of the pediatric ring for evaluation. A follow up report will be filed upon receipt of the device and completion of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2012-00239 |
| MDR Report Key | 2808981 |
| Report Source | 01,05,07 |
| Date Received | 2012-10-30 |
| Date of Report | 2013-03-01 |
| Date of Event | 2012-09-24 |
| Date Mfgr Received | 2013-03-01 |
| Date Added to Maude | 2012-10-30 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | LINDA REGAN |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 027670988 |
| Manufacturer Country | US |
| Manufacturer Postal | 027670988 |
| Manufacturer G1 | DEPUY RAYNHAM |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREMER LARGE PEDIATRIC RING |
| Generic Name | COMPONENT, TRACTION, INVASIVE |
| Product Code | JEC |
| Date Received | 2012-10-30 |
| Catalog Number | PT022 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY RAYNHAM |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-10-30 |